Sr. Associate Plant QA 12 Hour Night Shift (6pm- 6am)
Amgen
Full-time
Remote friendly (New Albany, OH)
United States
Operations
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Role Summary
Sr. Associate Plant QA Night Shift (6pm–6am) — provide QA guidance and support to production, perform Quality Batch Record Review of commercial batches, and support QA-related projects/systems. Establish effective relationships with production and other site staff to uphold quality and compliance.
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 support during internal/external regulatory inspections.
- Support Lean Transformation and Operational Excellence initiatives.
- Adhere to safety rules and maintain a safe work environment by supporting EHSS goals.
Qualifications
- Basic Qualifications:
- High school/GED + 4 years of Quality and/or GMP Manufacturing experience
- OR Associate’s + 2 years of Quality and/or GMP Manufacturing experience
- OR Bachelor’s + 6 months of Quality and/or GMP Manufacturing experience
- OR Master’s
- Preferred Qualifications:
- Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies
- Experience in 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, interpersonal skills
- Attention to detail and accuracy in GMP documentation
- Ability to work autonomously, provide updates to senior management, and identify potential issues
- Strong organizational skills and follow-through
- Direct experience with ERP software (SAP), TrackWise, CDOCS, etc.
Skills
- Quality assurance and GMP regulatory knowledge
- Documentation control and batch record review
- Problem solving and deviation/CAPA handling
- Cross-functional collaboration and communication
Education
- As listed in Qualifications (degrees as applicable)