Amgen Senior Associate Quality Assurance in West Greenwich, Rhode Island

The Senior Associate Quality Assurance will perform tactical activities across multiple quality system processes in support of External Quality oversight of Amgen's contract manufacturers and/or contract laboratories.

Responsibilities:

  • Serve as Owner or QA Contact for any External Quality Class 1 nonconformance records

  • Own CAPA records and drive required actions to completion

  • Support tracking of complaint investigations related to contract manufactured products and devices

  • Archive Amgen disposition batch packets

  • Generate LIMS batches and enter results obtained from contract manufacturing site into LIMS

  • Create Amgen Certificates of Analysis

  • Review documents generated by contract manufacturers including executed batch records, testing results, CofA, analytical methods, etc.

  • Escalate risks or roadblocks to appropriate level of management

  • Execute metric collection and review for contract manufacturing site teams

  • Support AFP and OE opportunities within External Quality

  • Serve as Owner/DV/QA Contact on data collection documents for APR

  • Interact with multiple departments and sites within Amgen

Basic Qualifications :

  • Master's degree

  • OR

  • Bachelor's degree and 2 years of Quality or Manufacturing experience

  • OR

  • Associate's degree and 6 years of Quality or Manufacturing experience

  • OR

  • High school diploma / GED and 8 years of Quality or Manufacturing experience

Preferred Qualifications :

  • 2+ years of quality and manufacturing experience in biotech or pharmaceutical industry

  • Bachelor's Degree in a Science Field

  • cGMP Experience

  • Able to successfully manage workload to timelines

  • Familiarity with basic project management tools

  • Demonstrated ability to consistently deliver on-time, and high-quality results

  • Ability to operate in a matrixed or team environment

  • Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative 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.

Amgen focuses on areas of high unmet medical need and leverages 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 all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.