Senior Plant QA | Remote/Hybrid Quality Leader

Regulatory Jobs; New Albany (OH); On-site; USD 82,000 - 111,000; Full time

Job summary

Amgen’s Quality team in Ohio seeks a Senior Associate Plant QA for day shifts to guide production staff, verify GMP operations, and review batch records. You will interact with operators, supervisors, and maintenance to ensure compliance with SOPs and quality systems.

The role requires GMP manufacturing experience and strong documentation skills, with opportunities to contribute to Lean initiatives and site-wide quality culture. Sponsorship not guaranteed; competitive benefits apply.

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

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 in case of production queries (quality related) during packaging and labeling operations.
• Lead, mentor, and coach Operations and support personnel on quality matters, while driving the site Quality culture.
• Review and approve batch production record and other GMP documentation in support of daily operations. 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 Standard Operating Procedures (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
• Adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting EHSS corporate and site goals.

Skills

GMP experience

Verbal and written communication

Strong organizational skills

Attention to detail

Autonomy in tasks

Digital innovation affinity

ERP familiarity

Education

High school/GED + 4 years of Quality and/or GMP Manufacturing experience

Associate’s + 2 years of Quality and/or GMP Manufacturing experience

Bachelor’s + 6 months of Quality and/or GMP Manufacturing experience

Master's

Tools

SAP

TrackWise

CDOCS

Job description

Amgen’s Quality team in Ohio seeks a Senior Associate Plant QA for day shifts to guide production staff, verify GMP operations, and review batch records. You will interact with operators, supervisors, and maintenance to ensure compliance with SOPs and quality systems.

The role requires GMP manufacturing experience and strong documentation skills, with opportunities to contribute to Lean initiatives and site-wide quality culture. Sponsorship not guaranteed; competitive benefits apply.