1+ months

Specialist QA

Juncos, Puerto Rico 00777
  • Job Code

Job ID: R-101660
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 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 support operations at the AML Inspection and Packaging Facility in a Non-Standard Shifts Operations. As Specialist QA you will bring forth out of the box thinking, an agile demeanor and proven subject matter expertise and innate understanding of Quality processes and controls in support of Supply Chain operations.

AML Supply Chain operations is a sophisticated organization that requires extensive coverage and Quality oversight. The Specialist QA that supports this organization will perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance program under general supervision.

A Day In The Life...

Through an outstanding Quality oversight on-the-floor, you will be responsible to ensure operations for clinical and licensed pharmaceutical products are manufactured, tested, stored, and distributed accordingly cGMP practices and other applicable regulations, in addition to facilities, equipment, materials, organization, processes, procedures and products.

Specific responsibilities include but are not limited to:

  • You will 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 Continues Improvement initiatives, programs and projects
  • Vigilant ensuring that changes that could potentially impact product quality are assessed according to procedures
  • Certify that deviations from established procedures are investigated and detailed per procedures
  • Ensures that production records and testing results are complete, accurate, and detailed according to written procedures and cGMP requirements
  • To be successful, you will require collaboration 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
  • Accountable for assigned training adherence to permit execution of required tasks
  • Champion Continuous Improvement initiatives and projects
  • Provides support and oversight of New Product Introduction (NPI)

Basic Education and Experience:

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

Preferred qualifications:

  • Educational background in Life Science or Engineering
  • Availability for Non-Standard shifts
  • 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
  • Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development
  • General knowledge in Validation of GxP applications.
  • 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
  • Sophisticated data trending and evaluation
  • Ability to evaluate compliance issues

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.

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

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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: 2020-07-15 Expires: 2020-08-15

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Specialist QA

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