10 days old

Specialist QA-Disposition

Amgen
Juncos, Puerto Rico 00777
  • Job Code
    123477564
Amgen

Job ID: R-104120
Location: Juncos, PR, US 00777

Are you looking for a meaningful new opportunity to test and growth your QUALITY skills? We have an immediate need for a SPECIALIST QUALITY ASSURANCE - DISPOSITION to join AML's Inspection & Packaging a Non Standard Shift 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

Specialist QA role will be responsible to perform a comprehensive quality assessment of all elements required to disposition a material or a product batch and capable of assessing batch records, analytical results, investigations, change controls and inventory transactions.

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
  • Review and approve product MPs.
  • Approve process validation protocols and reports for manufacturing processes.
  • Batch record review to support Complaints records.
  • Request Quality on incident triage team.
  • Approve Environmental Characterization reports.
  • Release of sanitary utility systems.
  • Approve planned incidents.
  • Represent QA on NPI team.
  • Lead investigations.
  • Lead site audits.
  • Own site quality program procedures.
  • Designee for QA manager on local CCRB.
  • Review Risk Assessments
  • Support Automation activities
  • Support facilities and environmental programs
  • Review and approve Work Orders
  • Review and approve EMS/BMS alarms
  • Approve NC investigations and CAPA records
  • Approve change controls
  • Provide lot disposition and authorize lots for shipment


BASIC QUALIFICATIONS

Doctorate degree

or

Master's degree and 3 years of experience in pharmaceutical or biotechnology manufacturing environment

or

Bachelor's degree and 5 years of experience in pharmaceutical or biotechnology manufacturing environment

PREFERRED QUALIFICATIONS

  • Educational Background in Biotechnology, Microbiology or Chemistry, Pharmacy
  • Strong oral and written communication skills.
  • Strong negotiating and leadership skills.
  • Ability to work within a matrix team environment
  • Able to operate in a fast paced, dynamic environment.
  • Good communicator to site management, Global Teams and within Regulatory Affairs-CMC (Global and Regional) teams.
  • Manage and execute RA-CMC activities to meet agreed upon timelines


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.



PI123477564

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Posted: 2020-09-10 Expires: 2020-10-11

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Specialist QA-Disposition

Amgen
Juncos, Puerto Rico 00777

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