Night Shift Plant QA Specialist - Batch Records

Amgen; New Albany (OH); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Retirement plan

Stock incentives

Flexible work models

Health coverage

Disability insurance

Annual bonus

Flexible spending accounts

Job summary

Amgen is seeking a Senior Associate Plant QA for the night shift to lead QA guidance at the AOH production site. You will review batch records, ensure GMP compliance, and collaborate with production, quality systems, and engineering teams.

The role emphasizes coaching staff on quality matters, participating in inspections, and contributing to continuous improvement and safety within a production environment.

Qualifications

• 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 degree in Life Sciences or related field preferred.

Responsibilities

• Provide daily QA guidance to Production staff and ensure SOP compliance.
• Monitor GMP operations in device assembly and packaging areas.
• Act as first QA contact for production queries during packaging and labeling.
• Lead and coach staff on quality matters and drive site quality culture.
• Review and approve batch production records and GMP documents.
• Perform finished product checks during production runs and prepare batch dispositions.
• Review deviations, CAPAs, and change controls; support regulatory inspections.
• Support Lean and Operational Excellence initiatives.

Skills

Quality GMP manufacturing

QA guidance

Documentation review

Education

Bachelor's degree

Associate's degree

Master's degree

High school diploma

Tools

SAP

TrackWise

CDOCS

Job description

Amgen is seeking a Senior Associate Plant QA for the night shift to lead QA guidance at the AOH production site. You will review batch records, ensure GMP compliance, and collaborate with production, quality systems, and engineering teams.

The role emphasizes coaching staff on quality matters, participating in inspections, and contributing to continuous improvement and safety within a production environment.