20 days old

Specialist QA - AML 14

Juncos, Puerto Rico 00777
  • Job Code

Job ID: R-103193
Location: Juncos, PR, US 00777

Are you a Quality professional with vast knowledge in Operations and drug product aseptic manufacturing processes?

Amgen is looking for an experienced Specialist QA aligned to a nonstandard work schedule for our Amgen Manufacturing Limited (AML) operation in Puerto Rico. As Specialist QA, you will bring forth out of the box thinking, an agile mindset and proven subject matter expertise with innate understanding of Quality processes and controls in support to our AML-14 large-scale 24/7 manufacturing plant.

The AML-14 Facility is the home of world-class multi-product drug product Manufacturing Operations. The facility highlights the combination of cutting edge manufacturing sciences and process technology, advanced equipment engineering and automation, and a dynamic culture integrating cross-functional teams from across the site with the goal of achieving being the best sterile biological drug product manufacturing facility in the world.

A Day In The Life... Through a superior Quality oversight on-the-floor operations, you will be responsible to ensure that pharmaceutical products are manufactured, tested, stored, and distributed according to cGMP practices and other applicable regulations, in addition to facilities, equipment, materials, organization, processes, procedures and products.

As part of your daily responsibilities you will be expected to:
  • Execute Quality disposition (approval or rejection) of bulk drug substances
  • Perform review, approval and tracking of cGMP processes, procedures, testing (methods) in manufacturing, documents and records, including but not limited to Deviation's, CAPAs, and validations
  • Actively engage in Continuous Improvement initiatives, programs and projects
  • Vigilantly ensure that changes that could potentially impact product quality are assessed according to procedures
  • Certify that deviations from established procedures are investigated and documented per procedures
  • Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
  • To be successful, you will be required to:
  • Strongly collaborate and partner cross functionally to ensure the Quality Management System processes are executed in accordance with established procedures
  • Strategically advise to senior management of quality, compliance, supply and safety risks
  • Support internal/external audits and inspections as part of the audit/inspection management team including acting as Quality unit representative as needed
  • Demonstrate accountability for assigned training adherence to permit execution of required tasks
  • Work will also include
  • Champion Continuous Improvement initiatives and projects
  • Provides support and oversight of New Product Introduction (NPI)
  • Support multidisciplinary initiatives and projects as manager back up upon request


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, Engineering or Computer Science
  • Validated expertise in Quality Systems such as Non Conformance, CAPA and Change Control
  • 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
  • Strong organizational skills, including ability to follow assignments through to completion
  • Good communications skills (oral and written) and comprehend in English and Spanish
  • 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
  • Proven skill in working independently and to effectively interact with all levels throughout the organization
  • Advanced data trending and evaluation
  • Ability to evaluate compliance issues

As Specialist Quality Assurance you will be unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering creative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

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.

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: 2020-08-29 Expires: 2020-09-29

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Specialist QA - AML 14

Juncos, Puerto Rico 00777

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