Sr. Associate Plant QA 12 Hour Night Shift (6pm- 6am)
Amgen
9 hours ago
On-site
New Albany, OH
Operations
Sr. Associate Plant QA Night Shift
What You Will Do
- Work in a shift system providing QA guidance and support to AOH production.
- Perform Quality Batch Record Review of all commercial batches labeled and packed at AOH.
- Support QA-related projects/systems.
- Establish effective working relationships with production operators, production line leads, production shift supervisors, warehouse, facilities, maintenance, and engineering.
Responsibilities
- Provide daily guidance and support to Production staff on compliance with Standard Operating Procedures (SOPs) and Work Instructions.
- Maintain regular presence in device assembly and packaging areas to monitor GMP operations and quality systems.
- Serve as first point of contact for quality-related production queries during packaging and labeling operations.
- Lead, mentor, and coach operations/support personnel on quality matters; drive the site Quality culture.
- Review and approve batch production records and other GMP documentation prior to production activities.
- 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 internal/external regulatory inspections.
- Support Lean Transformation and Operational Excellence initiatives.
- Follow safety rules and help maintain a safe work environment by supporting EHSS corporate and site goals.
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/knowledge of GMP/GCP operations or similarly regulated industry.
- Affinity with digital innovation, data sciences, and Quality engineering.
- Experience with raw material receipt, inspection, and sampling.
- Highly effective verbal and written communication; strong interpersonal skills.
- Attention to detail and high accuracy in task execution and GMP documentation.
- Ability to work autonomously; provide updates to senior management and identify potential issues.
- Strong organizational skills.
- Direct experience with Enterprise Resource Management software (e.g., SAP), TrackWise, CDOCS.
Benefits (explicitly mentioned)
- Retirement and Savings Plan (generous company contributions), group medical/dental/vision, life and disability insurance, flexible spending accounts.
- Discretionary annual bonus program (or sales-based incentive for field sales roles).
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models (remote/hybrid where possible).
Application Instructions
- Apply via careers.amgen.com.
What You Will Do
- Work in a shift system providing QA guidance and support to AOH production.
- Perform Quality Batch Record Review of all commercial batches labeled and packed at AOH.
- Support QA-related projects/systems.
- Establish effective working relationships with production operators, production line leads, production shift supervisors, warehouse, facilities, maintenance, and engineering.
Responsibilities
- Provide daily guidance and support to Production staff on compliance with Standard Operating Procedures (SOPs) and Work Instructions.
- Maintain regular presence in device assembly and packaging areas to monitor GMP operations and quality systems.
- Serve as first point of contact for quality-related production queries during packaging and labeling operations.
- Lead, mentor, and coach operations/support personnel on quality matters; drive the site Quality culture.
- Review and approve batch production records and other GMP documentation prior to production activities.
- 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 internal/external regulatory inspections.
- Support Lean Transformation and Operational Excellence initiatives.
- Follow safety rules and help maintain a safe work environment by supporting EHSS corporate and site goals.
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/knowledge of GMP/GCP operations or similarly regulated industry.
- Affinity with digital innovation, data sciences, and Quality engineering.
- Experience with raw material receipt, inspection, and sampling.
- Highly effective verbal and written communication; strong interpersonal skills.
- Attention to detail and high accuracy in task execution and GMP documentation.
- Ability to work autonomously; provide updates to senior management and identify potential issues.
- Strong organizational skills.
- Direct experience with Enterprise Resource Management software (e.g., SAP), TrackWise, CDOCS.
Benefits (explicitly mentioned)
- Retirement and Savings Plan (generous company contributions), group medical/dental/vision, life and disability insurance, flexible spending accounts.
- Discretionary annual bonus program (or sales-based incentive for field sales roles).
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models (remote/hybrid where possible).
Application Instructions
- Apply via careers.amgen.com.