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.
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 :
Bachelor's degree and 2 years of Quality or Manufacturing experience
Associate's degree and 6 years of Quality or Manufacturing experience
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
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.