27 días de edad

Specialist QA - Deviations Lifecycle team

Juncos, Puerto Rico 00777
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Job ID: R-103166
Location: Juncos, PR, US 00777

Are you looking for a meaningful new opportunity to test and growth your technical skills? We have an immediate need for Specialist QA's to join AML's Quality Drug Product Organization. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.

The Role

The Specialist QA role will be a member of the Deviation Lifecycle Team, supporting investigations to major deviation investigations and associated CAPA and CAPA EV records along with all the associated GMP documentation (procedures, testing results, risk assessments, etc). This position will focus in supporting AML Drug Product Operations consists of 3 plants, AML-1, AML-14, and AML-23, as well as the Process Development and Supply Chain Operations. The incumbent will be responsible to provide quality direction and establish requirements for the site major deviations.

As Specialist QA you will bring forth out of the box thinking, an agile attitude and proven subject matter expertise and innate understanding of Quality processes in drug product operations, including formulation, filling, inspection, assembly, packaging, and solid dosage operations. You will be responsible for the quality and compliance of major deviations.

  • Responsible for Major Deviations, CAPAs, CAPA EVs as Quality contact and all associated documents which include GMP document revision, and Quality System records with role of Quality contact.
  • Ensures true Root Cause are identified and appropriate corrective actions are implemented.
  • Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations
  • Supports Continual Improvement initiatives, programs and projects
  • Ensures that deviations from established procedures are investigated and detailed per procedures
  • Ensures that Quality Assurance personnel are qualified and trained to perform assigned functions in accordance with cGMP with requirements
  • Ensures the Quality Management System is implemented, maintained and reviewed in accordance with cGMP regulations
  • Alerts senior management of significant quality, compliance, supply and safety risks
  • Develops area goals, productivity projects, and tracks progress
  • Accountable for assigned training adherence to permit execution of required tasks
  • To be successful, you will require teamwork and partnership cross functionally to ensure the Quality Management System processes are executed in accordance with established procedures
  • Strategic advisor to senior management of quality, compliance, supply and safety risks
  • Supports internal/external audits and inspections as part of the audit/inspection management team including acting as Quality unit representative as needed


Doctor degree


Master's degree and 3 years of Quality or Manufacturing experience in GMP regulated environment


Bachelor's degree and 5 years of Quality or Manufacturing experience in GMP regulated environment

  • Educational background in Life Science or Engineering
  • Validated expertise in Quality Systems such as Non Conformance, CAPA, and Change Control
  • Experience in electronic systems such as: Maximo, ARMS, Trackwise, LIMS and SAP
  • Experience in computer systems validation or computer systems quality assurance (medical device and/or consulting background Technical proficiency)
  • Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development
  • Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements
  • Validated experience as Quality Contact for complex projects involving packaging, inspection, and new products
  • Validated experience in Commissioning and Qualification
  • Strong organizational skills, including ability to follow assignments through to completion
  • Enhanced skills in leading, influencing and negotiating
  • Demonstrate ability to interact with regulatory agencies
  • Solid word processing, presentation, database and spreadsheet application skills
  • Strong communication (both written and oral), facilitation and presentation skills
  • Validated skill in working independently and to effectively interact with all levels throughout the organization
  • Ability to evaluate compliance issues

The benefits:

Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer an outstanding benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program - and on-site childcare and fitness facilities - you will find us

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.



Posted: 2020-08-27 Expires: 2020-09-27

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Specialist QA - Deviations Lifecycle team

Juncos, Puerto Rico 00777

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