14 Quality Control Assistant jobs in Puerto Rico
Quality Assurance Auditor
Posted 1 day ago
Job Viewed
Job Description
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 ( .
Quality Assurance Technician
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
Director Quality Assurance (Parenteral)
Posted 2 days ago
Job Viewed
Job Description
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
Vice President Quality Assurance
Posted 2 days ago
Job Viewed
Job Description
+ 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.
Senior Specialist, Quality Assurance
Posted 8 days ago
Job Viewed
Job Description
**_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 (
Quality Assurance Auditor- Parenterals
Posted 9 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 no-style="text-align:left;">Job Function:
QualityJob Sub Function:
Quality AssuranceJob Category:
ProfessionalAll Job Posting Locations:
Gurabo, Puerto Rico, United States of AmericaJob Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at are searching for the best talent for Quality Assurance Auditor- Parenterals (Third Shift) to be located in Gurabo, PR.
As the QA Auditor, you will be accountable for ensuring the compliance with material specifications, current Good Manufacturing Practices, written procedures, Company Global Standards and Quality Agreements during batch record review related to the manufacturing and/or packaging of a product, comprehending raw materials, drug substances, finished product, and packaging components for Parenteral-Large Molecules Area.
Key Responsibilities:
Collaborate with Operations, Logistics, Warehouse, Technical Operations, Site Services, Quality Assurance and QC Laboratories to address potential compliance issues in a proactive way in order to deliver product on time. Make the appropriate recommendations and decisions to prevent process and/or product deviations.
Perform and document Process and Facility Quality Audit in a Parenteral Manufacturing and Utility Areas according to established Procedures, cGMP and J&J Standards.
Assure, prior conducting certification of a batch, that all regulated items established by current procedures, current specifications, quality agreements or customers are considered. Ensure all related documentation and samples for the specific stage have been taken and been indicated accordingly in Batch record documentation.
Coordinate and conduct AQL Inspection to finish Parenteral Products and oversight the inspection of materials and products to ensure finished product quality.
Support the cycle time reduction in batch records review and release. Assure that products are approved on time and to minimize product backorder situations related to Product Disposition performance and to optimize quality oversight and production activities.
Provides compliance support to Manufacturing and Packaging Operations to assure execution in compliance with cGMPs, Company J&J Global Standards, Company Policies, Quality Agreements, Batch Records, current specifications and current procedures.
Provide immediate actions and support in the timely resolution of quality and compliance matters that may include product segregation, product recalls and product approval/rejection.
Perform SAP transactions to ensure good Inventory practices of Parenteral Manufacturing Materials according to the established standards.
Qualifications
Education:
A minimum of Bachelor's degree is required. Focused degree in Microbiology, Biology, Chemistry or related science is preferred
Experience and Skills:
Required:
At least 2 years of overall work experience
Knowledge in documents such as safety rules, Standard Operating Procedures, Work instructions, investigations, validation reports, and protocols
Proficiency with Microsoft Office tools (Word, Excel, PowerPoint)
Must exercise judgment on the resolution of final release problems to meet company standards for quality, cost and critical success factors.
Preferred:
Knowledge or experience in Parenteral manufacturing process
Knowledge in current systems such as but not limited to SAP, Compliance Wire, Documentation System, Investigation System (Track Wise), LIMS
Certified Quality Auditor (CQA), Green Belt, Lean Manufacturing, and/or Kaizen certifications
Other:
Proficiency in both languages English and Spanish (oral and written) is required.
This position requires availability for working the third shift , including irregular (non-standard) shifts and weekends.
Ability to travel domestic up to 10% of the time
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 & 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, external applicants please contact us via , internal employees contact AskGS to be directed to your accommodation resource.
#LI-Onsite
Director Quality Assurance (Parenteral)
Posted 17 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 no-style="text-align:left;">Job Function:
QualityJob Sub Function:
Quality AssuranceJob Category:
People LeaderAll Job Posting Locations:
Gurabo, Puerto Rico, United States of AmericaJob 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 no-style="text-align:inherit;">
Be The First To Know
About the latest Quality control assistant Jobs in Puerto Rico !
Manager Quality Assurance - All Suites
Posted 15 days ago
Job Viewed
Job Description
This is your chance to be part of an in-house Brands team of industry experts in the domains of hospitality, brand management, innovation, food and beverage, wellness, owner relations, and more, for all of Hilton's unique brands! As Manager, QA Auditor, you will support the team that leads our brands with the steadfast goal of strengthening and growing the Hilton portfolio. On the Brands team reporting to Area Manager Quality Assurance, you will perform numerous QA audits and have responsibility for 100 hotels in your territory. Your main duty is to protect the integrity of the brands inspected in terms of cleanliness, condition, guest safety, and brand standards.
**HOW WE WILL SUPPORT YOU**
Hilton is proud to support the mental and physical wellbeing of all Team Members so they can Thrive personally and professionally in a diverse and inclusive environment, thanks to programs and benefits such as:
+ Go Hilton travel program: 110 nights of discounted travel with room rates as low as $40/night
+ Hilton Shares: Our employee stock purchase program (ESPP) - you can purchase Hilton shares at a 15 percent discount
+ Paid parental leave for eligible Team Members, including partners and adoptive parents
+ Mental health resources including free counseling through our Employee Assistance Program
+ Paid Time Off (PTO)
+ Learn more about the rest of our benefits
At Hilton, we believe every Team Member is a leader. We are committed to offering leadership development opportunities and programs through every step of a Team Member's career journey and at every level, both in our hotels and across corporate.
**Available benefits may vary depending upon terms and conditions of employment and are subject to the terms and conditions of the plans.
**HOW YOU WILL MAKE AN IMPACT**
Your role is important and below are some of the fundamental job duties that make your work unique.
**What your day-to-day will be like:**
+ Perform routine Quality Assurance evaluations.
+ Address inquiries and communications made internally, both verbally and in written communications.
+ Monitor expenses incurred from travel completed/scheduled, both based upon monthly and yearly goals.
+ Participate in Consistency exercises.
+ Participate in activities outside of QA to gain a better knowledge of other departments.
**How you will collaborate with others:**
+ Communicate with Quality Auditors, Area Managers in QA, Directors, Vice President of QA, Brand teams, Design and Construction, and Human Resources to answer inquiries about brand standard compliance, QA, brand protocol, procedures, and Improvement Plans.
**What projects you will take ownership of:**
+ Coordinate upcoming activities such as travel plans and hotel scheduling, ensuring downtime work is completed and submitted by established deadlines.
**WHY YOU'LL BE A GREAT FIT**
**You have these minimum qualifications:**
+ Five (5) years of management experience - Hotel Operations
+ Three (3) years of experience as a General Manager, Executive Committee Member, or Director in a Full-Service Hotel
+ Valid Driver's license
+ Travel 90% of the time
**It would be useful if you have:**
+ BA/BS Bachelor's Degree
+ Fluency in a foreign language
+ Food Safety certification
+ Project management skills
+ Working knowledge of product replacement cycles, renovations and physical upgrades
+ Problem resolution and consulting skills to mitigate potential conflicts/issues with general managers, owners, and/or internal customers while upholding the integrity of the brand
+ Current resident in the state of Georgia or South Carolina
**WHAT IT IS LIKE WORKING FOR HILTON**
Hilton, the #1 World's Best Workplace, is a leading global hospitality company with a diverse portfolio of world-class brands . Dedicated to filling the earth with the light and warmth of hospitality, we have welcomed more than 3 billion guests in our more-than 100-year history. Hilton is proud to have an award-winning workplace culture and we are consistently named among one of the World's Best Workplaces. Check out the Hilton Careers blog and Instagram to learn more about what it's like to be on Team Hilton!
It is the policy of Hilton to employ qualified persons without regard to color, race, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and related medication conditions), gender identity or gender expression, sexual orientation, marital status, military service, status as a protected veteran, disability, protected medical condition as defined by applicable law, genetic information, or any other protected group status as defined by and subject to applicable federal, state and local laws.
We provide reasonable accommodations to qualified persons with disabilities to perform the essential functions of the position and provide other benefits and privileges of employment in accordance with applicable law. Please contact us if you require an accommodation during the application process.
Hilton offers its eligible team members a comprehensive benefits package including medical and prescription drug coverage, dental coverage, vision coverage, life insurance, short-and long-term disability insurance, access to our employee stock purchase plan (ESPP) where you can purchase Hilton shares at a 15 percent discount, a 401(k) savings plan, 20 days of paid time off accruing over your first year of employment and increasing up to 25 days after completing one year of full employment, up to 12 weeks of paid leave for birth parents and 4 weeks for non-birth parents, 10 paid holidays and 2 floating holidays throughout the year, up to 5 bereavement days, flexible spending accounts, a health savings account, an employee assistance program, access to a care coordination program ("Wellthy"), a legal services program, an educational assistance program, adoption assistance, a backup childcare program, pre-tax commuter benefit and our travel discount. The annual salary range for this role is $5,000 - 110,000 and is determined based on applicable and specialized experience and location. Subject to plan terms and conditions, you will be eligible to participate in the Hilton Annual Incentive (Bonus) Plan, consistent with other team members at the same level and/or position within the Company.#LI-REMOTE
**Job:** _Brands_
**Title:** _Manager Quality Assurance - All Suites_
**Location:** _null_
**Requisition ID:** _COR015C5_
**EOE/AA/Disabled/Veterans**
Supervisor I, Quality Assurance (2nd Shift)
Posted 6 days ago
Job Viewed
Job 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
Purpose
The Quality Assurance Supervisor I is responsible for the organization, administration, and supervision of Quality Assurance employees within the manufacturing operations. Responsible for properly overseeing the day-to-day operations by prioritizing shop floor presence and receiving guidance and direction from more senior leaders. This includes delivering high levels of customer service, ensure quality of product and services, comply with all regulatory requirements, achieve desired financial performance including cost reductions, and build a culture of high performance for the team. Ensures that appropriate controls are developed and maintained for new, intermediate and finished products. Responsible for GMP compliance, manufacturing quality, product control and release, system execution and quality planning for the manufacturing areas that it supports.
Responsibilities
+ Responsible for leading a high performing team and prioritizing presence with the team.
+ Leads a team in the Quality function & is responsible for hiring, setting performance expectations, driving team engagement, providing continuous & on-time performance feedback, developing staff, assisting team in problem-solving, & handling of employee matters. Ensures that the department has the appropriate talent & level of performance to meet business objectives. Monitors administration of training identifies training needs, & development of team.
+ Provide Quality support on the manufacturing shop floor
+ Responsible for supporting Operations efforts in meeting established production schedule
+ Partner with Operations employees to document exception documents, including re-inspection and resolve other outstanding plant quality/compliance issues
+ Propose changes update, author, and implement departmental procedures consistent with objectives of simplification and process efficiencies/improvements which ensure ongoing compliance
+ Investigate QC hold, quarantine and reject for materials not meeting standards, ensure the initiation of exception documentation and oversee the implementation of any corrective action
+ Responsible for the review and approval of Procedures and Change Requests
+ Assist/serve/provide feedback on continuous improvement initiatives/teams
+ Reviews and releases batch records.
May serve as a backup when the Quality Manager is unavailable. Performs other tasks/projects as assigned.
Significant Work Activities:
+ Frequent to continuous computer usage (greater or equal to 50% of the workday) is required
Qualifications
Qualifications
+ Bachelor's degree in sciences or engineering.
+ 2+ years of experience in a manufacturing production environment.
+ Experience in regulated pharmaceutical, biotechnology or medical device industry is preferred.
+ Thorough knowledge of Quality Assurance operations including safety, application of FDA and GMP regulations.
+ Direct manufacturing and regulatory interface experience is preferred.
+ Effective problem-solving, decision-making, teamwork, influence, negotiation, and conflict resolution skills required
+ Ability to work cross-functionally and coordinate work both within the department and with other departments.
+ Ability to identify, communicate, and follow through to completion and assist in the development of necessary corrective action plans to resolve problems with supervision
+ Demonstrated strong leadership skills and ability to foster an inclusive environment
+ Experience managing SAP, Sample Manager or LIMS software is highly desired.
The selected candidate must be available to work on an extended second shift and weekends.
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:
Design Quality Assurance Engineer II (Hybrid-Puerto Rico)
Posted 15 days ago
Job Viewed
Job Description
**Country:**
United States of America
**Location:**
HPR01: Collins Puerto Rico- Aguadilla Road 110 North Km 28.8 San Antonio Industrial Park, Aguadilla, PR, 00603 USA
**Position Role Type:**
Unspecified
**U.S. Citizen, U.S. Person, or Immigration Status Requirements:**
The ability to obtain and maintain a U.S. government issued security clearance is required.
U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance
**Security Clearance:**
None/Not Required
Collins Aerospace is looking to hire a highly motivated and talented **Design Quality Assurance Engineer** with a strong interest in software design and quality work.
This position will be at our **Aguadilla, PR** location. You must be residing in Puerto Rico at the time of starting employment. Relocation is not offered.
This role is categorized as **hybrid** , with 3 days onsite and 2 days remote following the schedule assigned by the Manager.
**What YOU will do:**
+ Establish rapport across the organization, including leadership, engineering teams, shared service teams, and customers.
+ Assist with engineering project planning activities to ensure plans account for regulatory and customer requirements and incorporates best practices and lessons learned.
+ Assess proactively the health of design projects using objective measurements and assessments.
+ Review products and processes for compliance to requirements and program directives and review work practices for adequacy.
+ Advise project teams and leadership of design quality trends and systemic issues, using quality methods and tools to investigate, determine root cause, and recommend corrective actions.
**What YOU will learn:**
+ You will learn about our growing engineering team in Puerto Rico; What we do? Who we support? How we work?
+ You will learn the technologies of today and tomorrow which we count on to maintain world leadership in the aerospace industry.
+ You will learn why employees enjoy and feel fulfilled by working in our industry.
**Qualifications you must have:**
+ Typically requires a degree in Science, Technology, Engineering or Mathematics (STEM) and minimum 2 years of prior relevant experience or an Advanced Degree in a related field.
+ Demonstrated professional experience communicating in English (verbal and written).
+ U.S. citizenship is required, as only U.S. citizens are authorized to access information under this program/contract.
+ The ability to obtain and maintain a U.S. government issued security clearance is required
**Qualifications We Prefer:**
+ Knowledge of DO178, CMMI, AS9100, AS9115, AS9145, and DO-254 standards.
+ Experience conducting technical research and interpreting standards for application (e. g. ASE, ISO, IEEE, DoD, DFARs, etc.)
+ Experience with Agile and/or DevOps software development
+ Experience in a quality role of any kind is desirable.
+ Knowledge of or experience with design and development lifecycle, particularly requirements verification, validation and product integration
**What We Offer**
Some of our competitive benefits package includes:
+ Medical, dental, and vision insurance
+ Three weeks of vacation for newly hired employees
+ Generous 401(k) plan that includes employer matching funds
+ Participation in the Employee Scholar Program (ESP)
+ Life insurance and disability coverage
+ Employee Assistance Plan, including up to 8 free counseling sessions.
+ And more!
**Learn More & Apply Now!**
Collins Aerospace, an RTX business, is a leader in technologically advanced and intelligent solutions for the global aerospace and defense industry. Collins Aerospace has the capabilities, comprehensive portfolio, and expertise to solve customers' toughest challenges and to meet the demands of a rapidly evolving global market.
Join our growing team in Puerto Rico, where you will provide critical support to all Collins SBUs, working on exciting programs and projects ranging from the development of the next generation of advanced concept ejection seats to the latest technologies for the U.S. warfighter.
**WE ARE REDEFINING AEROSPACE.**
* Please consider the following role type definition as you apply for this role.
**Hybrid:** Employees who are working in Hybrid roles will work regularly both onsite and offsite. Ratio of time working onsite will be determined in partnership with your leader.
At Collins, the paths we pave together lead to limitless possibility. And the bonds we form - with our customers and with each other -- propel us all higher, again and again.
Apply now and be part of the team that's redefining aerospace, every day.
_RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act._
**Privacy Policy and Terms:**
Click on this link ( to read the Policy and Terms
Raytheon Technologies is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other federally protected class.