4 Production Management jobs in Manati
Supervisor Quality Control
00617 Utuado, Puerto Rico
Abbott
Posted 6 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 13 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 1 day 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:
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