Sr Associate PQA
Amgen
Full-time
Remote friendly (New Albany, OH)
United States
Operations
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Role Summary
Sr Associate PQA
Join Amgen’s Mission of Serving Patients. The Sr. Associate Plant QA for the new Amgen Advanced Assembly and Final Product Operation facility will provide QA oversight to GMP operations in the Device Assembly and Finished Product Packaging Area, supporting multiple production functions to achieve site goals while ensuring compliance. This role requires local presence at the New Albany facility and involves QA guidance, batch record review, and involvement in QA-related projects and systems.
Responsibilities
- Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures and Work Instructions.
- Ensure regular presence in device assembly and packaging areas to monitor GMP operations and quality systems.
- Act as a first point of contact for quality-related production queries during packaging and labeling operations.
- Lead, mentor, and coach Operations and support personnel on quality matters, driving the site Quality culture.
- Review and approve batch production records and other GMP documentation in support of daily operations; perform data entries before production activities take place.
- Perform finished product checks during commercial production runs.
- Compile and review batch records for lots assembled, packaged, and labeled at AOH in preparation for batch disposition.
- Own, review, and approve controlled documents, including SOPs, Work Instructions, and Forms.
- Review and approve Deviation, CAPA, and Change Control records.
- Participate in self-led inspections and provide support during internal/external regulatory inspections.
- Support Lean Transformation and Operational Excellence initiatives.
- Adhere to safety rules and maintain a safe work environment in alignment with EHSS goals.
Qualifications
- Basic Qualifications:
- High school/GED + 4 years Quality and/or GMP Manufacturing experience
- OR Associate’s + 2 years Quality and/or GMP Manufacturing experience
- OR Bachelor’s + 6 months Quality and/or GMP Manufacturing experience
- OR Master’s degree
- Preferred Qualifications:
- Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies
- Experience with GMP/GCP operations or similarly regulated industry
- Affinity with digital innovation, data sciences and Quality engineering
- Experience with raw material receipt, inspection & sampling
- Strong verbal and written communication and interpersonal skills
- Attention to detail and accuracy in GMP documentation
- Ability to complete tasks autonomously and provide updates to senior management
- Strong organizational skills and follow-through
- Experience with ERP software (SAP), TrackWise, CDOCS, etc.
Skills
- Quality oversight of GMP operations
- Documentation control and batch record review
- Deviation, CAPA, and Change Control management
- Regulatory inspection support
- Cross-functional collaboration with production, maintenance, and engineering
Education
- Not specified beyond qualifications above; degrees as noted in Preferred Qualifications.
Additional Requirements
- Local presence at the New Albany facility; willingness to work in a shift system.