Senior Plant QA - Quality Lead (Hybrid/Remote)

Amgen Inc.; New Albany (OH); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based incentives

Flexible work models

Job summary

Amgen Inc. in Ohio seeks a Senior Associate Plant QA for day shift to ensure batch record integrity and GMP compliance on commercial production.

You will provide QA guidance to production staff, review batch records, and support deviations, CAPA and change controls, collaborating with operations, quality, and maintenance teams. The role requires strong knowledge of GMP, SOPs, and document control, with experience in SAP or related ERP systems.

Qualifications

• 4+ years of Quality and/or GMP Manufacturing experience required.
• Experience with SOPs, CAPA, deviations and change controls preferred.
• Bachelor’s or Master’s degree with related GMP exposure is advantageous.

Responsibilities

• Provide daily QA guidance to Production staff on SOPs and Work Instructions.
• Review batch production records and ensure GMP compliance.
• Lead and support deviations, CAPA, and Change Control processes.

Skills

Quality assurance

GMP Manufacturing

Education

High school/GED

Associate’s

Bachelor’s

Master’s

Tools

SAP

TrackWise

CDOCS

Job description

Amgen Inc. in Ohio seeks a Senior Associate Plant QA for day shift to ensure batch record integrity and GMP compliance on commercial production.

You will provide QA guidance to production staff, review batch records, and support deviations, CAPA and change controls, collaborating with operations, quality, and maintenance teams. The role requires strong knowledge of GMP, SOPs, and document control, with experience in SAP or related ERP systems.