Supervisor Quality Control
00617 Utuado, Puerto Rico
Abbott
Posted 7 days ago
Job Viewed
Job Description
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
**About Abbott**
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.
**Working at Abbott**
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
+ Career development with an international company where you can grow the career you dream of.
+ Health Insurance (starting on Day 1 of employment), Savings Plan (401K) with company match, Life insurance for you and your spouse/children, Short Term Disability, Long Term Disability, Education Assistance, Employee Assistance Program, Vacation, Sick, Personal Days.
+ A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
+ A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
**The Opportunity**
This position works out of our Abbott Vascular Plant in Barceloneta, Puerto Rico at the **2nd second shift Monday to Friday** . The **Supervisor Quality Control** is responsible for the performance of the quality technicians and meeting daily production / operational / department demands. He/she will work with line supervisor, manufacturing engineer, quality engineer, and other team members, to address all opportunities found in the manufacturing lines and will the primary quality representative for the quarantine area. The individual performing this role will have to ensure proper management of resources while ensure quality and compliance of employees/equipment, promotion of safe and positive work environment, constant pursuit of operational excellence and continuous improvement, and achieving results through cross-functional collaboration with Management, Operations, Manufacturing Engineering, Equipment, and Quality Engineering. He/She will be accountable for QC inspector cross-training, rotation and for ensuring all manufacturing lines in all shifts have adequate QC support. He/She and will serve as the QA management representative in the manufacturing line, executing initiatives and working directly with the DL workforce.
**What You'll Do**
+ The Quality Supervisor is responsible for the performance of his or her team and meeting any assigned project timelines and objectives.
+ Develops goals /objectives for all assigned personnel. Monitors employees' performance against goals and provide performance feedback. Write and conduct development plans, as well as performance appraisals. Manage employees HR issues.
+ Maintaining the line audit ready at all times through assurance of procedural readiness, housekeeping, material and product controls, mix up risks and through continuous evaluation (audit) of the product and process.
+ Supervises, plans, coordinates, monitors and directs activities related to the eLHR review and approval finished lots in a timely manner.
+ Makes changes as appropriate to QC inspection procedures to aid in compliance and productivity assurance. Supports the Operations Supervisor and works as a liaison between functional departments to respond to technical issues on the line.
+ Approval of QC document related change orders, as needed.
+ Responsible for other quality related areas (eg. Microbiology, Chemical Testing, QCRI) and its performance.
+ Works to improve efficiency of QC inspectors. Works towards preventing/eliminating human related errors in area.
+ Works with line support team (Mfg Supervisor, Quality Engineer and Manufacturing Engineer) to perform line situation triage and determine if non-conformance is present, determine initial bracketing and containment, and initiate exception management process when required.
+ Responsible for quarantine area. Ensures non-conforming product is contained, segregated, and appropriately labeled.
+ Supports Quality Engineering department with data gathering, analysis and containment activities, as needed.
+ Runs moderate problem-solving efforts with minimal oversight and draws conclusions from the data as it relates to the quality issue under investigation. Responsible for standardization of inspection processes across similar lines and operations.
+ Responsible for the development of QC standard work. Able to confront and resolve conflict and support efforts to resolve critical situations.
+ Uses good judgment to make sound decisions.
+ This position requires a high level of adaptability, flexibility, clear direction and creative decision-making in a highly challenging environment.
+ Responsible for communication to Management and other stakeholders of new quality events.
+ Owns moderate CAPA activities related to area with minimal oversight.
+ Support AVPR projects, as needed.
**CAN'T WAIT TO GET STARTED?**
To be successful in this role, you will require the following qualifications:
+ Minimum 2 years of relevant experience in Quality and/or Compliance, preferably in medical device industry.
+ Bachelor's degree in science
+ Knowledge of applicable US & non-US applicable regulations.
+ Knowledge and proficiency in the application and principles of Quality Engineering.
+ Ability to effectively communicate cross-functionally to assist with resolving Quality issues.
+ Excellent written, verbal and interpersonal communication skills.
+ Ability to interact effectively with all levels of employees.
+ Strong technical knowledge and application of quality engineering concepts, practices and procedures.
+ Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors.
+ Demonstrated initiative and problem-solving skills; critical-thinking skills. Ability to direct activities of employees.
+ Ability to train and motivate assigned personnel.
+ Must be able to lead and motivate people to ensure safety, quality and performance.
The base pay for this position is $53,300.00 - $106,700.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
**About Abbott**
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.
**Working at Abbott**
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
+ Career development with an international company where you can grow the career you dream of.
+ Health Insurance (starting on Day 1 of employment), Savings Plan (401K) with company match, Life insurance for you and your spouse/children, Short Term Disability, Long Term Disability, Education Assistance, Employee Assistance Program, Vacation, Sick, Personal Days.
+ A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
+ A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
**The Opportunity**
This position works out of our Abbott Vascular Plant in Barceloneta, Puerto Rico at the **2nd second shift Monday to Friday** . The **Supervisor Quality Control** is responsible for the performance of the quality technicians and meeting daily production / operational / department demands. He/she will work with line supervisor, manufacturing engineer, quality engineer, and other team members, to address all opportunities found in the manufacturing lines and will the primary quality representative for the quarantine area. The individual performing this role will have to ensure proper management of resources while ensure quality and compliance of employees/equipment, promotion of safe and positive work environment, constant pursuit of operational excellence and continuous improvement, and achieving results through cross-functional collaboration with Management, Operations, Manufacturing Engineering, Equipment, and Quality Engineering. He/She will be accountable for QC inspector cross-training, rotation and for ensuring all manufacturing lines in all shifts have adequate QC support. He/She and will serve as the QA management representative in the manufacturing line, executing initiatives and working directly with the DL workforce.
**What You'll Do**
+ The Quality Supervisor is responsible for the performance of his or her team and meeting any assigned project timelines and objectives.
+ Develops goals /objectives for all assigned personnel. Monitors employees' performance against goals and provide performance feedback. Write and conduct development plans, as well as performance appraisals. Manage employees HR issues.
+ Maintaining the line audit ready at all times through assurance of procedural readiness, housekeeping, material and product controls, mix up risks and through continuous evaluation (audit) of the product and process.
+ Supervises, plans, coordinates, monitors and directs activities related to the eLHR review and approval finished lots in a timely manner.
+ Makes changes as appropriate to QC inspection procedures to aid in compliance and productivity assurance. Supports the Operations Supervisor and works as a liaison between functional departments to respond to technical issues on the line.
+ Approval of QC document related change orders, as needed.
+ Responsible for other quality related areas (eg. Microbiology, Chemical Testing, QCRI) and its performance.
+ Works to improve efficiency of QC inspectors. Works towards preventing/eliminating human related errors in area.
+ Works with line support team (Mfg Supervisor, Quality Engineer and Manufacturing Engineer) to perform line situation triage and determine if non-conformance is present, determine initial bracketing and containment, and initiate exception management process when required.
+ Responsible for quarantine area. Ensures non-conforming product is contained, segregated, and appropriately labeled.
+ Supports Quality Engineering department with data gathering, analysis and containment activities, as needed.
+ Runs moderate problem-solving efforts with minimal oversight and draws conclusions from the data as it relates to the quality issue under investigation. Responsible for standardization of inspection processes across similar lines and operations.
+ Responsible for the development of QC standard work. Able to confront and resolve conflict and support efforts to resolve critical situations.
+ Uses good judgment to make sound decisions.
+ This position requires a high level of adaptability, flexibility, clear direction and creative decision-making in a highly challenging environment.
+ Responsible for communication to Management and other stakeholders of new quality events.
+ Owns moderate CAPA activities related to area with minimal oversight.
+ Support AVPR projects, as needed.
**CAN'T WAIT TO GET STARTED?**
To be successful in this role, you will require the following qualifications:
+ Minimum 2 years of relevant experience in Quality and/or Compliance, preferably in medical device industry.
+ Bachelor's degree in science
+ Knowledge of applicable US & non-US applicable regulations.
+ Knowledge and proficiency in the application and principles of Quality Engineering.
+ Ability to effectively communicate cross-functionally to assist with resolving Quality issues.
+ Excellent written, verbal and interpersonal communication skills.
+ Ability to interact effectively with all levels of employees.
+ Strong technical knowledge and application of quality engineering concepts, practices and procedures.
+ Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors.
+ Demonstrated initiative and problem-solving skills; critical-thinking skills. Ability to direct activities of employees.
+ Ability to train and motivate assigned personnel.
+ Must be able to lead and motivate people to ensure safety, quality and performance.
The base pay for this position is $53,300.00 - $106,700.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
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0
Quality Control Coordinator
Vega Baja, Puerto Rico
Transmed Corp
Posted today
Job Viewed
Job Description
Job Description
Job Description
Descripción de PuestoQuality Control Cordinator – Facturación y Registros (Puesto Exento)
Departamento: Oficina Administrativa
Reporta a: Presidente
Ubicación: Oficina Central
Garantizar la exactitud y consistencia de los registros y documentación utilizada para la facturación de servicios de transporte en ambulancia, verificando que cumplan con los requisitos internos, contractuales y regulatorios. Auditar y evaluar tanto los reportes de choferes y paramédicos como la facturación generada por el personal de Facturación, supervisar el cumplimiento de funciones clave del personal de Despacho en relación con el cierre de casos y documentación en el sistema Pockets, y contribuir a la eficiencia operativa y la transparencia de los procesos.
Responsabilidades Principales- Verificar que las facturas emitidas por el personal de Facturación estén correctas y basadas en datos completos y validados.
- Auditar y revisar los registros de transporte realizados por choferes y paramédicos para asegurar que la información esté completa, precisa y conforme a las políticas de la empresa.
- Confirmar que Despacho monitoree diariamente, por turno, que no queden casos abiertos en sistema y, de ser necesario, que proceda a cerrarlos.
- Identificar errores, omisiones o inconsistencias y canalizar las correcciones, según los protocolos establecidos. Deberá reportar a la gerencia cualquier incumplimiento.
- Preparar informes periódicos de hallazgos y recomendaciones dirigidos al Presidente de la Empresa.
- Mantener actualizados los formatos y procedimientos para la captura de datos y facturación.
- Coordinar con las distintas áreas para asegurar el cumplimiento de estándares de calidad.
- Manejar información confidencial con el más alto nivel de integridad.
- Cumplir con otras tareas afines que le sean asignadas por el Presidente.
Requisitos del Puesto- Educación: Grado Asociado o Bachillerato en Administración de Empresas, Contabilidad, Facturación Médica o área relacionada (preferible).
- Experiencia: Mínimo 1 año en funciones administrativas, facturación médica, auditorías o control de calidad.
- Conocimientos Técnicos: Dominio de Microsoft Word, Excel y Google Sheets; manejo de sistemas administrativos y herramientas de análisis de datos.
- Competencias Clave: Atención rigurosa al detalle, habilidad para analizar información y proponer mejoras, organización y manejo eficiente del tiempo, comunicación escrita y verbal efectiva, discreción y manejo de información confidencial.
Condiciones del Puesto- Clasificación: Exento, bajo criterios administrativos y de confianza.
- Modalidad: Presencial en Oficina Central y a distancia de ser requerido.
- Reporta directamente al Presidente de la Empresa y sigue sus instrucciones directas.
- Jornada: Tiempo completo, con disponibilidad para atender situaciones urgentes según sea requerido.
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1
Senior Coordinator, Quality Control
00918 San Juan, Puerto Rico
Cardinal Health
Posted 14 days ago
Job Viewed
Job Description
Cardinal Health Sonexus Access and Patient Support helps specialty pharmaceutical manufacturers remove barriers to care so that patients can access, afford and remain on the therapy they need for a better quality of life. Our diverse expertise in pharma, payer and hub services allows us to deliver best-in-class solutions-driving brand and patient markers of success. We're continuously integrating advanced and emerging technologies to streamline patient onboarding, qualification, and adherence. Our non-commercial specialty pharmacy is centralized at our custom-designed facility outside of Dallas, Texas, empowering manufacturers to rethink the reach and impact of their products.
**Together, we can get life-changing therapies to patients who need them-faster.**
**What Performance Monitoring contributes to Cardinal Health:**
Performance Monitoring is responsible for establishing, maintaining, and enhancing customer business through contract administration, customer orders, and problem resolution. Performance Monitoring is responsible for monitoring, analyzing, and reviewing customer contact quality.
**Responsibilities:**
+ Evaluate calls and cases to assess performance based on a standard set of criteria, providing constructive feedback and recognition to employees to ensure high performance and continuous improvement.
+ Accurately score transactions to gauge employee's quality performance based on organizational and departmental policies and requirements.
+ Monitor and evaluate team performance, whether voice or non-voice, of assigned entity and team, ensuring adherence to company quality standards, and compliance with industry regulations.
+ Track and report any trends from the customer experience that can be improved or celebrated.
+ Analyze and provide weekly & monthly trend analysis to leadership.
+ Provide support to leadership by participating in and hosting internal/external client calibration sessions.
+ Engage in and lead projects to promote quality enhancements and/or broaden services for the team.
+ Maintain a comprehensive understanding of quality systems and methodologies as well as knowledge of applicable regulations, standards, and operating procedures.
+ Conduct investigations/root cause analysis and formulate corrective action recommendations.
+ Show an understanding of the program requirements and be capable of conducting gap assessments based on those requirements.
+ Uphold quality standards that adhere to company, regulatory, and HIPAA policies and procedures.
+ Collaborate across various functions, interpret requirements, educate and influence others regarding those requirements.
+ Identify training needs or potential disciplinary actions which will be reported to leadership.
+ Build strong customer relationships and deliver customer-centric solutions.
+ Optimize work processes by identifying effective and efficient methods to complete tasks, with an emphasis on continuous improvement.
+ Develop strategic alliances and cooperate with stakeholders to achieve mutual goals.
+ Demonstrate resourcefulness by adeptly securing and efficiently deploying resources.
+ Analyze complex and high-quality, sometimes contradictory, information to solve problems effectively.
+ Hold oneself and others accountable for meeting commitments and objectives.
+ Exhibit situational adaptability by adjusting approach and demeanor in real time to meet the changing demands of various situations.
+ Create and implement diverse communication strategies that clearly address the specific requirements of various target audiences.
**Qualifications:**
+ HS Diploma, GED or technical certification in related field or equivalent experience, preferred. Diploma or degree in relevant field desirable.
+ 3+ years' call quality audit experience strongly preferred.
+ 3+ years' experience in a patient support program or hub field would be an asset.
+ Adverse Event reporting and reconciliation experience strongly preferred.
+ Data collection and trend reporting experience is essential for this role.
+ Proficiency in MS Office applications required - Outlook, Excel, PowerPoint, and Word.
+ Excellent verbal and written communication skills.
+ High regard for superior quality of service.
+ Ability to prioritize and manage multiple responsibilities.
+ Experience handling tasks where attention to detail is critical to success.
+ Bilingual Spanish would be an asset.
**What is expected of you and others at this level:**
+ Demonstrates strong leadership and collaboration skills with a proven ability to develop and execute effective quality assurance programs.
+ Works independently within established procedures; may receive general guidance on new assignments.
+ May provide general guidance or technical assistance to less experienced team members.
+ Excellent attention to detail and problem-solving skills.
+ Strong communication and interpersonal skills.
+ Ability to analyze data and generate reports.
+ Ability to drive process improvements and implement quality assurance procedures.
**TRAINING AND WORK SCHEDULES** : Your new hire training will take place 8:00am-5:00pm CST, mandatory attendance is required.
This position is full-time (8-hour shifts, 40 hours/week). Employees are required to have flexibility to work any of our shift schedules during our normal business hours of Monday-Friday, 7:00am- 8:00pm CST.
**REMOTE DETAILS:** You will work remotely, full-time. It will require a dedicated, quiet, private, distraction free environment with access to high-speed internet. We will provide you with the computer, technology and equipment needed to successfully perform your job. You will be responsible for providing high-speed internet. Internet requirements include the following:
+ Maintain a secure, high-speed, broadband internet connection (DSL, Cable, or Fiber) at the remote location. Dial-up, satellite, WIFI, Cellular connections are NOT acceptable.
+ Download speed of 15Mbps (megabyte per second)
+ Upload speed of 5Mbps (megabyte per second)
+ Ping Rate Maximum of 30ms (milliseconds)
+ Hardwired to the router
+ Surge protector with Network Line Protection for CAH issued equipment
**Anticipated hourly range:** $21.90 per hour - $31.40 per hour
**Bonus eligible:** No
**Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
+ Medical, dental and vision coverage
+ Paid time off plan
+ Health savings account (HSA)
+ 401k savings plan
+ Access to wages before pay day with myFlexPay
+ Flexible spending accounts (FSAs)
+ Short- and long-term disability coverage
+ Work-Life resources
+ Paid parental leave
+ Healthy lifestyle programs
**Application window anticipated to close:** 10/10/2025. If interested in opportunity, please submit application as soon as possible.
The hourly range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
+ Works independently within established procedures; may receive general guidance on new assignments
+ May provide general guidance or technical assistance to less experienced team members
_Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._
_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._
_To read and review this privacy notice click_ here (
**Together, we can get life-changing therapies to patients who need them-faster.**
**What Performance Monitoring contributes to Cardinal Health:**
Performance Monitoring is responsible for establishing, maintaining, and enhancing customer business through contract administration, customer orders, and problem resolution. Performance Monitoring is responsible for monitoring, analyzing, and reviewing customer contact quality.
**Responsibilities:**
+ Evaluate calls and cases to assess performance based on a standard set of criteria, providing constructive feedback and recognition to employees to ensure high performance and continuous improvement.
+ Accurately score transactions to gauge employee's quality performance based on organizational and departmental policies and requirements.
+ Monitor and evaluate team performance, whether voice or non-voice, of assigned entity and team, ensuring adherence to company quality standards, and compliance with industry regulations.
+ Track and report any trends from the customer experience that can be improved or celebrated.
+ Analyze and provide weekly & monthly trend analysis to leadership.
+ Provide support to leadership by participating in and hosting internal/external client calibration sessions.
+ Engage in and lead projects to promote quality enhancements and/or broaden services for the team.
+ Maintain a comprehensive understanding of quality systems and methodologies as well as knowledge of applicable regulations, standards, and operating procedures.
+ Conduct investigations/root cause analysis and formulate corrective action recommendations.
+ Show an understanding of the program requirements and be capable of conducting gap assessments based on those requirements.
+ Uphold quality standards that adhere to company, regulatory, and HIPAA policies and procedures.
+ Collaborate across various functions, interpret requirements, educate and influence others regarding those requirements.
+ Identify training needs or potential disciplinary actions which will be reported to leadership.
+ Build strong customer relationships and deliver customer-centric solutions.
+ Optimize work processes by identifying effective and efficient methods to complete tasks, with an emphasis on continuous improvement.
+ Develop strategic alliances and cooperate with stakeholders to achieve mutual goals.
+ Demonstrate resourcefulness by adeptly securing and efficiently deploying resources.
+ Analyze complex and high-quality, sometimes contradictory, information to solve problems effectively.
+ Hold oneself and others accountable for meeting commitments and objectives.
+ Exhibit situational adaptability by adjusting approach and demeanor in real time to meet the changing demands of various situations.
+ Create and implement diverse communication strategies that clearly address the specific requirements of various target audiences.
**Qualifications:**
+ HS Diploma, GED or technical certification in related field or equivalent experience, preferred. Diploma or degree in relevant field desirable.
+ 3+ years' call quality audit experience strongly preferred.
+ 3+ years' experience in a patient support program or hub field would be an asset.
+ Adverse Event reporting and reconciliation experience strongly preferred.
+ Data collection and trend reporting experience is essential for this role.
+ Proficiency in MS Office applications required - Outlook, Excel, PowerPoint, and Word.
+ Excellent verbal and written communication skills.
+ High regard for superior quality of service.
+ Ability to prioritize and manage multiple responsibilities.
+ Experience handling tasks where attention to detail is critical to success.
+ Bilingual Spanish would be an asset.
**What is expected of you and others at this level:**
+ Demonstrates strong leadership and collaboration skills with a proven ability to develop and execute effective quality assurance programs.
+ Works independently within established procedures; may receive general guidance on new assignments.
+ May provide general guidance or technical assistance to less experienced team members.
+ Excellent attention to detail and problem-solving skills.
+ Strong communication and interpersonal skills.
+ Ability to analyze data and generate reports.
+ Ability to drive process improvements and implement quality assurance procedures.
**TRAINING AND WORK SCHEDULES** : Your new hire training will take place 8:00am-5:00pm CST, mandatory attendance is required.
This position is full-time (8-hour shifts, 40 hours/week). Employees are required to have flexibility to work any of our shift schedules during our normal business hours of Monday-Friday, 7:00am- 8:00pm CST.
**REMOTE DETAILS:** You will work remotely, full-time. It will require a dedicated, quiet, private, distraction free environment with access to high-speed internet. We will provide you with the computer, technology and equipment needed to successfully perform your job. You will be responsible for providing high-speed internet. Internet requirements include the following:
+ Maintain a secure, high-speed, broadband internet connection (DSL, Cable, or Fiber) at the remote location. Dial-up, satellite, WIFI, Cellular connections are NOT acceptable.
+ Download speed of 15Mbps (megabyte per second)
+ Upload speed of 5Mbps (megabyte per second)
+ Ping Rate Maximum of 30ms (milliseconds)
+ Hardwired to the router
+ Surge protector with Network Line Protection for CAH issued equipment
**Anticipated hourly range:** $21.90 per hour - $31.40 per hour
**Bonus eligible:** No
**Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
+ Medical, dental and vision coverage
+ Paid time off plan
+ Health savings account (HSA)
+ 401k savings plan
+ Access to wages before pay day with myFlexPay
+ Flexible spending accounts (FSAs)
+ Short- and long-term disability coverage
+ Work-Life resources
+ Paid parental leave
+ Healthy lifestyle programs
**Application window anticipated to close:** 10/10/2025. If interested in opportunity, please submit application as soon as possible.
The hourly range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
+ Works independently within established procedures; may receive general guidance on new assignments
+ May provide general guidance or technical assistance to less experienced team members
_Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._
_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._
_To read and review this privacy notice click_ here (
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2
Senior Manager, Quality Control Laboratory
00617 Utuado, Puerto Rico
AbbVie
Posted 2 days ago
Job Viewed
Job Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
Ensures quality control and quality assurance compliance across the manufacturing site. Serves as an integral member of QC leadership team with a focus on ensuring quality system requirements are achieved. Leads the site quality control unit and serves as the primary backup to the QC Head.
Responsibilities:
+ Lead the biologics site Raw Materials and Incoming Materials laboratory processes and programs for a high volume, high level of product complexity including multi products to ensure compliance with regulations including EU Annex 1, FDA Guidalines, EMA, ANSI, among others. Ensure robustness and approves investigations Raw Materials & Incoming, quality and process excursions or incident.
+ Direct RM & Incoming laboratory operations and programs such as RM & Incoming methods for materials, excipients, API, commodities. Testing of raw materials, commodities, USP water and cleaning samples.
+ Responsible for elevating to the appropriate levels of management within Quality Operations Senior Management of significant quality issues in a timely fashion. Reviews and approves laboratory instrumentation, utilities, and facilities qualification and labs system life cycle documentation.
+ Responsible for all raw and incoming materials and commodities (including ERP approval) in the Quality Control (QC) laboratory including direct reports and budgetary responsibilities.
+ Serves as the standalone laboratory systems and site Maximo administrator. Comply with AbbVie policies, ABL plant procedures, Food and Drug Administration (FDA), EMA, and other applicable regulatory agencies cGMP regulations and requirements.
+ Responsible for end results of the Incoming Quality Assurance area. Assures that all incoming materials received at ABL are inspected, sampled, tested, and disposition according to established policies and procedures. Provides strategic direction for area of operation and ensures tactical objectives are met.
+ Responsible for front- and back-room support activities for the RM and Incoming Lab during internal audits, Periodic Validation Review, Annual Product Reviews, and process data reviews and inspections.
+ Represents the decision-making authority on change related to compendia, supplier/service provider notifications, material specifications, analytical test methods, test method validation, SOPs, batch records, and site service requests. Leads the implementation of Quality-related projects, including metrics.
+ Manages a team of quality professionals. Directly responsible for the effective organization, administration, training, and supervision of their functional area.
+ Exception Report (ER) investigation, writing, review, and approval including ensuring effective CAPAs; qualification and validation protocol writing, review, and approval.
Significant Work Activities:
+ Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
+ Continuous walking for prolonged periods (more than 2 consecutive hours in an 8 hr. day) is required
+ Frequent to continuous computer usage (greater or equal to 50% of the workday) is required
Qualifications
+ Bachelor's degree Science (Chemistry or Biology) with 10 years of pharmaceutical (parenteral biologics preferred) Quality experience (preferably in QC) or an equivalent combination of education and experience.
+ Experience managing raw and incoming materials.
+ Knowledge in raw materials /Incoming Materials programs under ANSI guidelines is required.
+ Supplier Quality Programs knowledge and experience.
+ The selected candidate must be fully bilingual written and verbal, both in English and Spanish.
+ Experience with SmartQC, LIMS (Sample Manager), Empower is desired.
+ Previous experience leading teams.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
+ The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
+ We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
+ This job is eligible to participate in our short-term incentive programs.
+ This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
Ensures quality control and quality assurance compliance across the manufacturing site. Serves as an integral member of QC leadership team with a focus on ensuring quality system requirements are achieved. Leads the site quality control unit and serves as the primary backup to the QC Head.
Responsibilities:
+ Lead the biologics site Raw Materials and Incoming Materials laboratory processes and programs for a high volume, high level of product complexity including multi products to ensure compliance with regulations including EU Annex 1, FDA Guidalines, EMA, ANSI, among others. Ensure robustness and approves investigations Raw Materials & Incoming, quality and process excursions or incident.
+ Direct RM & Incoming laboratory operations and programs such as RM & Incoming methods for materials, excipients, API, commodities. Testing of raw materials, commodities, USP water and cleaning samples.
+ Responsible for elevating to the appropriate levels of management within Quality Operations Senior Management of significant quality issues in a timely fashion. Reviews and approves laboratory instrumentation, utilities, and facilities qualification and labs system life cycle documentation.
+ Responsible for all raw and incoming materials and commodities (including ERP approval) in the Quality Control (QC) laboratory including direct reports and budgetary responsibilities.
+ Serves as the standalone laboratory systems and site Maximo administrator. Comply with AbbVie policies, ABL plant procedures, Food and Drug Administration (FDA), EMA, and other applicable regulatory agencies cGMP regulations and requirements.
+ Responsible for end results of the Incoming Quality Assurance area. Assures that all incoming materials received at ABL are inspected, sampled, tested, and disposition according to established policies and procedures. Provides strategic direction for area of operation and ensures tactical objectives are met.
+ Responsible for front- and back-room support activities for the RM and Incoming Lab during internal audits, Periodic Validation Review, Annual Product Reviews, and process data reviews and inspections.
+ Represents the decision-making authority on change related to compendia, supplier/service provider notifications, material specifications, analytical test methods, test method validation, SOPs, batch records, and site service requests. Leads the implementation of Quality-related projects, including metrics.
+ Manages a team of quality professionals. Directly responsible for the effective organization, administration, training, and supervision of their functional area.
+ Exception Report (ER) investigation, writing, review, and approval including ensuring effective CAPAs; qualification and validation protocol writing, review, and approval.
Significant Work Activities:
+ Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
+ Continuous walking for prolonged periods (more than 2 consecutive hours in an 8 hr. day) is required
+ Frequent to continuous computer usage (greater or equal to 50% of the workday) is required
Qualifications
+ Bachelor's degree Science (Chemistry or Biology) with 10 years of pharmaceutical (parenteral biologics preferred) Quality experience (preferably in QC) or an equivalent combination of education and experience.
+ Experience managing raw and incoming materials.
+ Knowledge in raw materials /Incoming Materials programs under ANSI guidelines is required.
+ Supplier Quality Programs knowledge and experience.
+ The selected candidate must be fully bilingual written and verbal, both in English and Spanish.
+ Experience with SmartQC, LIMS (Sample Manager), Empower is desired.
+ Previous experience leading teams.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
+ The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
+ We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
+ This job is eligible to participate in our short-term incentive programs.
+ This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
View Now
3
Quality Assurance Technician
00674 Manati, Puerto Rico
J&J Family of Companies
Posted today
Job Viewed
Job Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Quality
**Job Sub** **Function:**
Quality Control
**Job Category:**
Business Enablement/Support
**All Job Posting Locations:**
Manatí, Puerto Rico, United States of America
**Job Description:**
**About MedTech**
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at Surgery**
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that's reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.
Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent for Quality Assurance Technician.**
**Purpose** : Reports to the Quality Engineering Supervisor or Designee, with the objective of maintaining high Quality Standards for Product Quality Control and operations compliance with regulatory requirements. Conducts routine physical inspection procedure to in-process material, as well as finished goods, as needed. Inspection involves the use of skilled specifications and established quality standards. Performs audits to ensure product and processes comply with requirements.
**You will be responsible for** **:**
+ Maintains high Quality Standards for Product Quality Control and operations compliance with regulatory requirements.
+ Conducts routine physical inspection, testing, or evaluation to ensure quality of products according to current specifications/procedures.
+ Performs product and process audits.
+ Notify any product or process non-conformance and escalates as appropriate.
+ Segregates and inspects Finished Goods samples and Retain Samples according to the requirements. Delivers samples to Finished Goods QA Lab if needed.
+ Performs data analysis and executes final disposition of the material as required.
+ Performs batch records review accordingly with compliance requirements and complete record retention process.
+ Maintain knowledge of all procedures, change to specifications and new regulations related to their areas of responsibility.
+ Ensures on-time completion of assigned trainings.
+ Support associates on defect awareness and specifications requirements.
**Qualifications / Requirements:**
+ High School Diploma and one (1) year of experience in a regulated industry ; or Bachelor's Degree in a technical or science field is required.
+ One (1) year of Quality assurance experience is preferred.
+ Knowledge of QSR's and ISO Standards is required.
+ PC literacy including MS Office and use of other software and applications is required.
+ Verbal and written communication skills in English and Spanish are required.
+ Availability to work overtime, various work schedules, which may include 1st, 2nd, 3rd shifts and/or 12-hour daily shifts, including weekends and holidays is required.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.
#LI-Onsite
Quality
**Job Sub** **Function:**
Quality Control
**Job Category:**
Business Enablement/Support
**All Job Posting Locations:**
Manatí, Puerto Rico, United States of America
**Job Description:**
**About MedTech**
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at Surgery**
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that's reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.
Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent for Quality Assurance Technician.**
**Purpose** : Reports to the Quality Engineering Supervisor or Designee, with the objective of maintaining high Quality Standards for Product Quality Control and operations compliance with regulatory requirements. Conducts routine physical inspection procedure to in-process material, as well as finished goods, as needed. Inspection involves the use of skilled specifications and established quality standards. Performs audits to ensure product and processes comply with requirements.
**You will be responsible for** **:**
+ Maintains high Quality Standards for Product Quality Control and operations compliance with regulatory requirements.
+ Conducts routine physical inspection, testing, or evaluation to ensure quality of products according to current specifications/procedures.
+ Performs product and process audits.
+ Notify any product or process non-conformance and escalates as appropriate.
+ Segregates and inspects Finished Goods samples and Retain Samples according to the requirements. Delivers samples to Finished Goods QA Lab if needed.
+ Performs data analysis and executes final disposition of the material as required.
+ Performs batch records review accordingly with compliance requirements and complete record retention process.
+ Maintain knowledge of all procedures, change to specifications and new regulations related to their areas of responsibility.
+ Ensures on-time completion of assigned trainings.
+ Support associates on defect awareness and specifications requirements.
**Qualifications / Requirements:**
+ High School Diploma and one (1) year of experience in a regulated industry ; or Bachelor's Degree in a technical or science field is required.
+ One (1) year of Quality assurance experience is preferred.
+ Knowledge of QSR's and ISO Standards is required.
+ PC literacy including MS Office and use of other software and applications is required.
+ Verbal and written communication skills in English and Spanish are required.
+ Availability to work overtime, various work schedules, which may include 1st, 2nd, 3rd shifts and/or 12-hour daily shifts, including weekends and holidays is required.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.
#LI-Onsite
View Now
4
Quality Assurance Auditor
00918 San Juan, Puerto Rico
Datavant
Posted 2 days ago
Job Viewed
Job Description
Datavant is a data platform company and the world's leader in health data exchange. Our vision is that every healthcare decision is powered by the right data, at the right time, in the right format.
Our platform is powered by the largest, most diverse health data network in the U.S., enabling data to be secure, accessible and usable to inform better health decisions. Datavant is trusted by the world's leading life sciences companies, government agencies, and those who deliver and pay for care.
By joining Datavant today, you're stepping onto a high-performing, values-driven team. Together, we're rising to the challenge of tackling some of healthcare's most complex problems with technology-forward solutions. Datavanters bring a diversity of professional, educational and life experiences to realize our bold vision for healthcare.
**What We're Looking For:**
We are seeking a Quality Assurance Auditor to ensure operational effectiveness, regulatory compliance, and continuous process improvement across medical records workflows. This role is critical to safeguarding patient information, ensuring adherence to HIPAA and regulatory standards, and supporting process enhancements that improve accuracy, efficiency, and compliance.
**What You Will Do:**
Work remotely from anywhere in the United States
+ **Audit & Quality Control:**
+ Review the accuracy of pended requests to confirm medical records in HealthSource are captured correctly.
+ Perform quality checks to ensure compliance with HIPAA, state/federal laws, client-specific requirements, and invoicing standards.
+ Identify workflow issues, error trends, and delays; recommend corrective actions to leadership.
+ Conduct audits of request and fulfillment processes to verify adherence to Standard Operating Procedures (SOPs).
+ Maintain thorough documentation of audit results, findings, and corrective actions.
+ Stay up to date on laws, fee structures, and facility policies governing the release of information.
+ **Process Improvement:**
+ Recommend and assist with process enhancements to increase efficiency and accuracy.
+ Collaborate with training and operations teams to address recurring issues and contribute to updated training materials or job aids.
+ **Compliance Monitoring:**
+ Ensure all requests meet HIPAA, HITECH, and other applicable regulatory standards for handling and releasing Protected Health Information (PHI).
+ Monitor adherence to client-specific service-level agreements (SLAs) and protocols.
+ **Training & Support:**
+ Provide feedback to team members based on audit outcomes.
+ Support onboarding and ongoing QA training for new hires focused on documentation accuracy and compliance.
+ Participate in required training sessions, staff meetings, and professional development activities.
+ Participate in monthly interrater reliability training with the Quality Assurance Audit Manager and team.
**What a Typical Day Looks Like**
In this role, you can expect to:
+ Collaborate with the quality team and cross-functional partners in operations, compliance, training, and data.
+ Conduct audits, capture results, and analyze trends.
+ Report findings to the Quality Assurance Audit Manager and recommend improvements.
+ Provide feedback and support to operational teams to ensure quality and compliance goals are met.
**What You Need to Succeed:**
+ **Experience:** Minimum 5 years in Release of Information (ROI) or health information operations (Datavant experience strongly preferred).
+ **Auditing Skills:** 1+ years in quality assurance or auditing with proven ability to evaluate processes, identify gaps, and recommend solutions.
+ **Education:** High school diploma required; Associate's or Bachelor's degree in Health Information Management, Healthcare Administration, or related field strongly preferred.
+ **Knowledge:** In-depth understanding of HIPAA, PHI handling standards, and medical record confidentiality.
+ **Technical Skills:** Proficiency in electronic health record (EHR) systems, request tracking tools, and Microsoft Office.
+ **Soft Skills:** Strong attention to detail, excellent communication, organizational skills, and the ability to problem-solve in a fast-paced environment.
+ **Professionalism:** Maintains confidentiality, strong rapport with colleagues, and forward-thinking approach to challenges.
**Analytical Skills:** Ability to analyze data and deliver actionable insights.
Pay ranges for this job title may differ based on location, responsibilities, skills, experience, and other requirements of the role.
The estimated base pay range per hour for this role is:
$21-$25 USD
To ensure the safety of patients and staff, many of our clients require post-offer health screenings and proof and/or completion of various vaccinations such as the flu shot, Tdap, COVID-19, etc. Any requests to be exempted from these requirements will be reviewed by Datavant Human Resources and determined on a case-by-case basis. Depending on the state in which you will be working, exemptions may be available on the basis of disability, medical contraindications to the vaccine or any of its components, pregnancy or pregnancy-related medical conditions, and/or religion.
This job is not eligible for employment sponsorship.
Datavant is committed to a work environment free from job discrimination. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. To learn more about our commitment, please review our EEO Commitment Statement here ( . Know Your Rights ( , explore the resources available through the EEOC for more information regarding your legal rights and protections. In addition, Datavant does not and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay.
At the end of this application, you will find a set of voluntary demographic questions. If you choose to respond, your answers will be anonymous and will help us identify areas for improvement in our recruitment process. (We can only see aggregate responses, not individual ones. In fact, we aren't even able to see whether you've responded.) Responding is entirely optional and will not affect your application or hiring process in any way.
Datavant is committed to working with and providing reasonable accommodations to individuals with physical and mental disabilities. If you need an accommodation while seeking employment, please request it here, ( by selecting the 'Interview Accommodation Request' category. You will need your requisition ID when submitting your request, you can find instructions for locating it here ( . Requests for reasonable accommodations will be reviewed on a case-by-case basis.
For more information about how we collect and use your data, please review our Privacy Policy ( .
Our platform is powered by the largest, most diverse health data network in the U.S., enabling data to be secure, accessible and usable to inform better health decisions. Datavant is trusted by the world's leading life sciences companies, government agencies, and those who deliver and pay for care.
By joining Datavant today, you're stepping onto a high-performing, values-driven team. Together, we're rising to the challenge of tackling some of healthcare's most complex problems with technology-forward solutions. Datavanters bring a diversity of professional, educational and life experiences to realize our bold vision for healthcare.
**What We're Looking For:**
We are seeking a Quality Assurance Auditor to ensure operational effectiveness, regulatory compliance, and continuous process improvement across medical records workflows. This role is critical to safeguarding patient information, ensuring adherence to HIPAA and regulatory standards, and supporting process enhancements that improve accuracy, efficiency, and compliance.
**What You Will Do:**
Work remotely from anywhere in the United States
+ **Audit & Quality Control:**
+ Review the accuracy of pended requests to confirm medical records in HealthSource are captured correctly.
+ Perform quality checks to ensure compliance with HIPAA, state/federal laws, client-specific requirements, and invoicing standards.
+ Identify workflow issues, error trends, and delays; recommend corrective actions to leadership.
+ Conduct audits of request and fulfillment processes to verify adherence to Standard Operating Procedures (SOPs).
+ Maintain thorough documentation of audit results, findings, and corrective actions.
+ Stay up to date on laws, fee structures, and facility policies governing the release of information.
+ **Process Improvement:**
+ Recommend and assist with process enhancements to increase efficiency and accuracy.
+ Collaborate with training and operations teams to address recurring issues and contribute to updated training materials or job aids.
+ **Compliance Monitoring:**
+ Ensure all requests meet HIPAA, HITECH, and other applicable regulatory standards for handling and releasing Protected Health Information (PHI).
+ Monitor adherence to client-specific service-level agreements (SLAs) and protocols.
+ **Training & Support:**
+ Provide feedback to team members based on audit outcomes.
+ Support onboarding and ongoing QA training for new hires focused on documentation accuracy and compliance.
+ Participate in required training sessions, staff meetings, and professional development activities.
+ Participate in monthly interrater reliability training with the Quality Assurance Audit Manager and team.
**What a Typical Day Looks Like**
In this role, you can expect to:
+ Collaborate with the quality team and cross-functional partners in operations, compliance, training, and data.
+ Conduct audits, capture results, and analyze trends.
+ Report findings to the Quality Assurance Audit Manager and recommend improvements.
+ Provide feedback and support to operational teams to ensure quality and compliance goals are met.
**What You Need to Succeed:**
+ **Experience:** Minimum 5 years in Release of Information (ROI) or health information operations (Datavant experience strongly preferred).
+ **Auditing Skills:** 1+ years in quality assurance or auditing with proven ability to evaluate processes, identify gaps, and recommend solutions.
+ **Education:** High school diploma required; Associate's or Bachelor's degree in Health Information Management, Healthcare Administration, or related field strongly preferred.
+ **Knowledge:** In-depth understanding of HIPAA, PHI handling standards, and medical record confidentiality.
+ **Technical Skills:** Proficiency in electronic health record (EHR) systems, request tracking tools, and Microsoft Office.
+ **Soft Skills:** Strong attention to detail, excellent communication, organizational skills, and the ability to problem-solve in a fast-paced environment.
+ **Professionalism:** Maintains confidentiality, strong rapport with colleagues, and forward-thinking approach to challenges.
**Analytical Skills:** Ability to analyze data and deliver actionable insights.
Pay ranges for this job title may differ based on location, responsibilities, skills, experience, and other requirements of the role.
The estimated base pay range per hour for this role is:
$21-$25 USD
To ensure the safety of patients and staff, many of our clients require post-offer health screenings and proof and/or completion of various vaccinations such as the flu shot, Tdap, COVID-19, etc. Any requests to be exempted from these requirements will be reviewed by Datavant Human Resources and determined on a case-by-case basis. Depending on the state in which you will be working, exemptions may be available on the basis of disability, medical contraindications to the vaccine or any of its components, pregnancy or pregnancy-related medical conditions, and/or religion.
This job is not eligible for employment sponsorship.
Datavant is committed to a work environment free from job discrimination. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. To learn more about our commitment, please review our EEO Commitment Statement here ( . Know Your Rights ( , explore the resources available through the EEOC for more information regarding your legal rights and protections. In addition, Datavant does not and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay.
At the end of this application, you will find a set of voluntary demographic questions. If you choose to respond, your answers will be anonymous and will help us identify areas for improvement in our recruitment process. (We can only see aggregate responses, not individual ones. In fact, we aren't even able to see whether you've responded.) Responding is entirely optional and will not affect your application or hiring process in any way.
Datavant is committed to working with and providing reasonable accommodations to individuals with physical and mental disabilities. If you need an accommodation while seeking employment, please request it here, ( by selecting the 'Interview Accommodation Request' category. You will need your requisition ID when submitting your request, you can find instructions for locating it here ( . Requests for reasonable accommodations will be reviewed on a case-by-case basis.
For more information about how we collect and use your data, please review our Privacy Policy ( .
View Now
5
Quality Assurance Technician
00674 Manati, Puerto Rico
Johnson and Johnson
Posted today
Job Viewed
Job Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at no-style="text-align:left;">Job Function:
QualityJob Sub Function:
Quality ControlJob Category:
Business Enablement/SupportAll Job Posting Locations:
Manatí, Puerto Rico, United States of AmericaJob Description:
About MedTech
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at Surgery
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.
Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent for Quality Assurance Technician.
Purpose : Reports to the Quality Engineering Supervisor or Designee, with the objective of maintaining high Quality Standards for Product Quality Control and operations compliance with regulatory requirements. Conducts routine physical inspection procedure to in-process material, as well as finished goods, as needed. Inspection involves the use of skilled specifications and established quality standards. Performs audits to ensure product and processes comply with requirements.
You will be responsible for :
- Maintains high Quality Standards for Product Quality Control and operations compliance with regulatory requirements.
- Conducts routine physical inspection, testing, or evaluation to ensure quality of products according to current specifications/procedures.
- Performs product and process audits.
- Notify any product or process non-conformance and escalates as appropriate.
- Segregates and inspects Finished Goods samples and Retain Samples according to the requirements. Delivers samples to Finished Goods QA Lab if needed.
- Performs data analysis and executes final disposition of the material as required.
- Performs batch records review accordingly with compliance requirements and complete record retention process.
- Maintain knowledge of all procedures, change to specifications and new regulations related to their areas of responsibility.
- Ensures on-time completion of assigned trainings.
- Support associates on defect awareness and specifications requirements.
Qualifications / Requirements:
- High School Diploma and one (1) year of experience in a regulated industry ; or Bachelor’s Degree in a technical or science field is required.
- One (1) year of Quality assurance experience is preferred.
- Knowledge of QSR's and ISO Standards is required.
- PC literacy including MS Office and use of other software and applications is required.
- Verbal and written communication skills in English and Spanish are required.
- Availability to work overtime, various work schedules, which may include 1st, 2nd, 3rd shifts and/or 12-hour daily shifts, including weekends and holidays is required.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.
#LI-Onsite
Apply Now
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6
Director Quality Assurance (Parenteral)
00778 Gurabo, Puerto Rico
J&J Family of Companies
Posted 3 days ago
Job Viewed
Job Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Quality
**Job Sub** **Function:**
Quality Assurance
**Job Category:**
People Leader
**All Job Posting Locations:**
Gurabo, Puerto Rico, United States of America
**Job Description:**
Johnson & Johnson is currently recruiting for a **Director, Quality Assurance (Parenteral)!** This position will be located in Gurabo, PR.
_At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healllthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at_ _ _._
**Position Summary:**
The Quality Assurance (QA) Director will be accountable for providing technical knowledge, direction, and support of assigned products including areas, such as Chemistry, Technology Transfer, Microbiology Laboratories and the Quality Assurance for the manufacture and final disposition of products. Responsible for ensuring the conformance of manufacturing, packaging and product transfers activities with the current Good Manufacturing Practices, Janssen policies, standards and internal procedures.
The QA Director will provide technical and compliance knowledge to ensure that the manufacture and management of the products have the appropriate systems and testing processes in place in compliance with cGMP and GLP, corporate standards, federal and international regulations, and industry practices. Supports the review and approval of procedures and specifications, significant investigations, product reviews, equipment/facility modification, and validation documents to ensure regulatory compliance. Leads discussions on solutions to problems with manufacturing processes, in-process product, final product release and product complaints to ensure timely resolution. Serves as the back up to the Site Quality Head of the Gurabo site.
**Key Responsibilities:**
+ Acts as the Parenteral site Management Representative in line with Johnson & Johnson Quality Policies and Health Authorities regulations.
+ Monitors and reviews the quality management system for compliance, effectiveness, and improvement opportunities.
+ Promotes awareness of regulatory requirements and monitors key quality performance measures.
+ Manages the CAPA system, reports to management, and initiates corrective/preventive actions.
+ Develops strategies for cGMP compliance, budget management, and operational structure for business needs.
+ Participates in product transfer teams to ensure compliance with cGMP and internal procedures.
+ Collaborates with Product and Analytical Development teams to address issues and schedule activities.
+ Supports product and technology launches and participates in stage gate reviews.
+ Partners with Compliance Team for internal audits and handles customer complaints in compliance with cGMP.
+ Leads Quality Risk Assessment exercises and ensures consistent manufacturing practices across sites.
+ Supervises, coaches, and develops assigned personnel; ensures training and performance assessments.
+ Recommends modifications to policies and participates in achieving strategic goals.
+ Observes and makes sure compliance with all company policies and regulations.
+ Supports Process Excellence Projects, ISO 14001 improvement, and Environmental and Safety initiatives.
+ Serves as the Site QA Qualified Person per China Drugs GMP Regulations.
**Qualifications - External**
**Education:**
A minimum of a Bachelor's or equivalent University degree with a focus in Chemistry, Pharmacy, Biochemistry, Chemical Engineering or related Science or Engineering preferred. Master's in science or Engineering is highly preferred.
**Experience and Skills:**
**Required:**
+ Minimum of 12years of experience in the pharmaceutical industry, ten of them in a parenteral operation.
+ Minimum eight (8) years of experience in a managerial role. Five (5) years of experience in Quality leadership role is required.
+ Knowledge in equipment and process validation, environmental conditions and monitoring, aseptic processing, technology transfer, release, regulatory, lyophilization and troubleshooting of aseptic and combination products.
+ Vast knowledge of lyophilization and sterilization processes preferred.
+ Shown experience in implementing quality systems. Develops and implements strategy for cGMP's compliance for the site.
+ Experience in regulated environmental (FDA, MHRA) and other worldwide regulatory agencies and management of regulatory inspections.
+ The position requires skills in problem-solving and analysis, including interpreting complex documents and preparing presentations. Candidates should be able to work both independently and in teams, follow technical instructions, meet deadlines, make precise decisions quickly, and possess strong interpersonal skills.
**Other:**
+ Be fluent in Spanish and English and must have excellent ability to write in English and Spanish.
+ Must exercise judgement on the resolution of production problems to meet company standards for quality, cost and critical success factors.
+ Availability for traveling, working irregular shifts, frequently requires working extended hours, and might be required to work on holidays and weekends.
+ Be proficient in the use of MS Office applications: Word, Excel, Power Point, and Internet.
+ Knowledge in process excellence and project management tools.
+ 10% Travel Requirements
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit
Quality
**Job Sub** **Function:**
Quality Assurance
**Job Category:**
People Leader
**All Job Posting Locations:**
Gurabo, Puerto Rico, United States of America
**Job Description:**
Johnson & Johnson is currently recruiting for a **Director, Quality Assurance (Parenteral)!** This position will be located in Gurabo, PR.
_At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healllthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at_ _ _._
**Position Summary:**
The Quality Assurance (QA) Director will be accountable for providing technical knowledge, direction, and support of assigned products including areas, such as Chemistry, Technology Transfer, Microbiology Laboratories and the Quality Assurance for the manufacture and final disposition of products. Responsible for ensuring the conformance of manufacturing, packaging and product transfers activities with the current Good Manufacturing Practices, Janssen policies, standards and internal procedures.
The QA Director will provide technical and compliance knowledge to ensure that the manufacture and management of the products have the appropriate systems and testing processes in place in compliance with cGMP and GLP, corporate standards, federal and international regulations, and industry practices. Supports the review and approval of procedures and specifications, significant investigations, product reviews, equipment/facility modification, and validation documents to ensure regulatory compliance. Leads discussions on solutions to problems with manufacturing processes, in-process product, final product release and product complaints to ensure timely resolution. Serves as the back up to the Site Quality Head of the Gurabo site.
**Key Responsibilities:**
+ Acts as the Parenteral site Management Representative in line with Johnson & Johnson Quality Policies and Health Authorities regulations.
+ Monitors and reviews the quality management system for compliance, effectiveness, and improvement opportunities.
+ Promotes awareness of regulatory requirements and monitors key quality performance measures.
+ Manages the CAPA system, reports to management, and initiates corrective/preventive actions.
+ Develops strategies for cGMP compliance, budget management, and operational structure for business needs.
+ Participates in product transfer teams to ensure compliance with cGMP and internal procedures.
+ Collaborates with Product and Analytical Development teams to address issues and schedule activities.
+ Supports product and technology launches and participates in stage gate reviews.
+ Partners with Compliance Team for internal audits and handles customer complaints in compliance with cGMP.
+ Leads Quality Risk Assessment exercises and ensures consistent manufacturing practices across sites.
+ Supervises, coaches, and develops assigned personnel; ensures training and performance assessments.
+ Recommends modifications to policies and participates in achieving strategic goals.
+ Observes and makes sure compliance with all company policies and regulations.
+ Supports Process Excellence Projects, ISO 14001 improvement, and Environmental and Safety initiatives.
+ Serves as the Site QA Qualified Person per China Drugs GMP Regulations.
**Qualifications - External**
**Education:**
A minimum of a Bachelor's or equivalent University degree with a focus in Chemistry, Pharmacy, Biochemistry, Chemical Engineering or related Science or Engineering preferred. Master's in science or Engineering is highly preferred.
**Experience and Skills:**
**Required:**
+ Minimum of 12years of experience in the pharmaceutical industry, ten of them in a parenteral operation.
+ Minimum eight (8) years of experience in a managerial role. Five (5) years of experience in Quality leadership role is required.
+ Knowledge in equipment and process validation, environmental conditions and monitoring, aseptic processing, technology transfer, release, regulatory, lyophilization and troubleshooting of aseptic and combination products.
+ Vast knowledge of lyophilization and sterilization processes preferred.
+ Shown experience in implementing quality systems. Develops and implements strategy for cGMP's compliance for the site.
+ Experience in regulated environmental (FDA, MHRA) and other worldwide regulatory agencies and management of regulatory inspections.
+ The position requires skills in problem-solving and analysis, including interpreting complex documents and preparing presentations. Candidates should be able to work both independently and in teams, follow technical instructions, meet deadlines, make precise decisions quickly, and possess strong interpersonal skills.
**Other:**
+ Be fluent in Spanish and English and must have excellent ability to write in English and Spanish.
+ Must exercise judgement on the resolution of production problems to meet company standards for quality, cost and critical success factors.
+ Availability for traveling, working irregular shifts, frequently requires working extended hours, and might be required to work on holidays and weekends.
+ Be proficient in the use of MS Office applications: Word, Excel, Power Point, and Internet.
+ Knowledge in process excellence and project management tools.
+ 10% Travel Requirements
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit
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7
Vice President Quality Assurance
00918 San Juan, Puerto Rico
Cytel
Posted 3 days ago
Job Viewed
Job Description
Cytel is seeking a visionary Vice President, Quality Assurance (QA) to lead our global QA function. This executive role ensures the highest standards of compliance with Good Clinical Practice (GCP) and international regulations, while driving innovation in quality oversight. The Vice President will provide strategic direction, oversee quality systems and audits, lead global inspection readiness, and build a high-performing QA team that partners with the business to deliver excellence.
+ Provide strategic leadership for Cytel's global QA organization, ensuring alignment with company objectives.
+ Oversee the Quality Management System (QMS), audits, vendor oversight, data integrity, and regulatory inspection readiness.
+ Drive adoption of risk-based quality management to improve efficiency and compliance.
+ Serve as Cytel's senior representative in regulatory inspections and engagements.
+ Partner with internal and external stakeholders to ensure quality practices support innovation and operational success.
+ Lead, mentor, and develop a global team of QA professionals, fostering collaboration, accountability, and growth.
+ Master's degree in life sciences, computer sciences, or related discipline; MBA preferred.
+ 15+ years of progressive QA leadership experience in pharmaceutical, biotechnology, or CRO environments.
+ Deep knowledge of GCP, ICH guidelines, and international regulatory inspection practices.
+ Proven success building and leading global QA teams in complex organizations.
+ Strong business acumen with experience in strategic planning, resource management, and executive-level decision-making.
+ Excellent communication, influencing, and leadership skills with the ability to thrive in a dynamic, fast-paced environment.
**Why Join Us?**
At Cytel, we are united by our mission to advance life sciences and improve patient outcomes. As part of our leadership team, you'll have the opportunity to shape the future of global quality practices, collaborate with world-class experts, and make a lasting impact on the industry. We offer a flexible and inclusive work environment, competitive compensation, and opportunities for professional growth in a company that values innovation, integrity, and excellence.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.
+ Provide strategic leadership for Cytel's global QA organization, ensuring alignment with company objectives.
+ Oversee the Quality Management System (QMS), audits, vendor oversight, data integrity, and regulatory inspection readiness.
+ Drive adoption of risk-based quality management to improve efficiency and compliance.
+ Serve as Cytel's senior representative in regulatory inspections and engagements.
+ Partner with internal and external stakeholders to ensure quality practices support innovation and operational success.
+ Lead, mentor, and develop a global team of QA professionals, fostering collaboration, accountability, and growth.
+ Master's degree in life sciences, computer sciences, or related discipline; MBA preferred.
+ 15+ years of progressive QA leadership experience in pharmaceutical, biotechnology, or CRO environments.
+ Deep knowledge of GCP, ICH guidelines, and international regulatory inspection practices.
+ Proven success building and leading global QA teams in complex organizations.
+ Strong business acumen with experience in strategic planning, resource management, and executive-level decision-making.
+ Excellent communication, influencing, and leadership skills with the ability to thrive in a dynamic, fast-paced environment.
**Why Join Us?**
At Cytel, we are united by our mission to advance life sciences and improve patient outcomes. As part of our leadership team, you'll have the opportunity to shape the future of global quality practices, collaborate with world-class experts, and make a lasting impact on the industry. We offer a flexible and inclusive work environment, competitive compensation, and opportunities for professional growth in a company that values innovation, integrity, and excellence.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.
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8
Senior Specialist, Quality Assurance
00918 San Juan, Puerto Rico
Cardinal Health
Posted 9 days ago
Job Viewed
Job Description
**Senior Specialist, Quality Assurance - Pharmaceutical Private Label (Labeling Team)**
**_What Quality Assurance contributes to Cardinal Health_**
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.
**_Job Summary_**
The Senior Specialist, Quality Assurance - Labeling Team is responsible for ensuring the accuracy, compliance, and quality of labeling components for pharmaceutical private label products. This role supports the Pharmaceutical Private Label operations by reviewing and approving labeling and maintaining documentation in accordance with current Good Manufacturing Practices (cGMP), FDA regulations, and internal procedures.
**_Responsibilities_**
**Labeling Review & Approval:**
+ Review and approve labeling components for all Pharmaceutical Private Label Cardinal Health owned brands.
+ Review and approve Master Batch Records from repackagers to ensure appropriate labeling utilized by repackagesr.
+ Determine criticality of label discrepancies using comparison software.
+ Review incoming source product labeling for accuracy and compliance.
**Documentation & Compliance/Process Improvement & Collaboration:**
+ Conduct gap assessments and proactively identify quality issues.
+ Develop, review, and implement QA procedures.
+ Collaborate across departments to ensure regulatory compliance and timely resolution of quality concerns.
**_Qualifications_**
+ 2-4 years of experience, preferred
+ Bachelor's degree in related field, or equivalent work experience, preferred
+ Working knowledge of cGMP and FDA regulations.
+ Experience with quality management systems and labeling platforms (e.g., Veeva, Kallik, Global Vision).
+ Strong attention to detail and decision-making skills.
+ Ability to work independently and manage moderately complex projects.
+ Effective communication and collaboration skills across cross-functional teams.
+ Ability to make decisions that prioritize quality of product and labeling that may conflict with production priorities and ability to communicate those decisions in a diplomatic, productive manner.
+ Knowledge of FDA drug and device listing requirements.
+ Knowledge of drug listing submission processes via the Electronic Submissions Gateway (ESG) preferred.
+ Familiarity with regulatory documentation and compliance standards for pharmaceutical and medical device labeling.
+ Ability to interpret and apply regulatory guidance to ensure labeling accuracy and compliance.
+ Experience in maintaining and updating labeling records and revision logs for RX and OTC products.
**_What is expected of you and others at this level_**
+ Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
+ Works on projects of moderate scope and complexity
+ Identifies possible solutions to a variety of technical problems and takes action to resolve
+ Applies judgment within defined parameters
+ Receives general guidance and may receive more detailed instruction on new projects
+ Work reviewed for sound reasoning and accuracy
**Anticipated salary range:** $68,500 - $87,400
**Bonus eligible:** No
**Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
+ Medical, dental and vision coverage
+ Paid time off plan
+ Health savings account (HSA)
+ 401k savings plan
+ Access to wages before pay day with myFlexPay
+ Flexible spending accounts (FSAs)
+ Short- and long-term disability coverage
+ Work-Life resources
+ Paid parental leave
+ Healthy lifestyle programs
**Application window anticipated to close:** 11/20/2025 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity
_Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._
_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._
_To read and review this privacy notice click_ here (
**_What Quality Assurance contributes to Cardinal Health_**
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.
**_Job Summary_**
The Senior Specialist, Quality Assurance - Labeling Team is responsible for ensuring the accuracy, compliance, and quality of labeling components for pharmaceutical private label products. This role supports the Pharmaceutical Private Label operations by reviewing and approving labeling and maintaining documentation in accordance with current Good Manufacturing Practices (cGMP), FDA regulations, and internal procedures.
**_Responsibilities_**
**Labeling Review & Approval:**
+ Review and approve labeling components for all Pharmaceutical Private Label Cardinal Health owned brands.
+ Review and approve Master Batch Records from repackagers to ensure appropriate labeling utilized by repackagesr.
+ Determine criticality of label discrepancies using comparison software.
+ Review incoming source product labeling for accuracy and compliance.
**Documentation & Compliance/Process Improvement & Collaboration:**
+ Conduct gap assessments and proactively identify quality issues.
+ Develop, review, and implement QA procedures.
+ Collaborate across departments to ensure regulatory compliance and timely resolution of quality concerns.
**_Qualifications_**
+ 2-4 years of experience, preferred
+ Bachelor's degree in related field, or equivalent work experience, preferred
+ Working knowledge of cGMP and FDA regulations.
+ Experience with quality management systems and labeling platforms (e.g., Veeva, Kallik, Global Vision).
+ Strong attention to detail and decision-making skills.
+ Ability to work independently and manage moderately complex projects.
+ Effective communication and collaboration skills across cross-functional teams.
+ Ability to make decisions that prioritize quality of product and labeling that may conflict with production priorities and ability to communicate those decisions in a diplomatic, productive manner.
+ Knowledge of FDA drug and device listing requirements.
+ Knowledge of drug listing submission processes via the Electronic Submissions Gateway (ESG) preferred.
+ Familiarity with regulatory documentation and compliance standards for pharmaceutical and medical device labeling.
+ Ability to interpret and apply regulatory guidance to ensure labeling accuracy and compliance.
+ Experience in maintaining and updating labeling records and revision logs for RX and OTC products.
**_What is expected of you and others at this level_**
+ Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
+ Works on projects of moderate scope and complexity
+ Identifies possible solutions to a variety of technical problems and takes action to resolve
+ Applies judgment within defined parameters
+ Receives general guidance and may receive more detailed instruction on new projects
+ Work reviewed for sound reasoning and accuracy
**Anticipated salary range:** $68,500 - $87,400
**Bonus eligible:** No
**Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
+ Medical, dental and vision coverage
+ Paid time off plan
+ Health savings account (HSA)
+ 401k savings plan
+ Access to wages before pay day with myFlexPay
+ Flexible spending accounts (FSAs)
+ Short- and long-term disability coverage
+ Work-Life resources
+ Paid parental leave
+ Healthy lifestyle programs
**Application window anticipated to close:** 11/20/2025 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity
_Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._
_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._
_To read and review this privacy notice click_ here (
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