Job Title:
Sr. Associate, Plant QA (12-Hour Night Shift | 6 PM – 6 AM)
Location:
United States – Ohio – New Albany
Work Type: On-site
Job ID: R-228505
Date Posted: October 21, 2025
Category: Quality
Salary Range: $84,323 – $102,972 USD (Annual)
About Amgen
Since 1980, Amgen has been a global pioneer in biotechnology, focused on improving the lives of patients with serious illnesses. With expertise across Oncology, Inflammation, General Medicine, and Rare Diseases, Amgen’s mission is to serve patients through scientific innovation and advanced manufacturing.
Our award-winning culture emphasizes collaboration, innovation, and a strong scientific foundation.
Role Summary
As a Senior Associate – Plant Quality Assurance (QA) on the Night Shift, you will provide on-floor QA oversight for manufacturing, labeling, and packaging operations at the Amgen Ohio (AOH) facility. You will play a key role in maintaining GMP compliance, reviewing batch records, and driving quality excellence across operations.
You will collaborate closely with production operators, shift supervisors, maintenance, warehouse, and engineering teams, ensuring quality standards are upheld in all plant activities.
Key Responsibilities
Operational QA Oversight
Provide daily QA guidance to Production teams to ensure compliance with SOPs and GMP standards.
Maintain a regular presence on the production floor to monitor operations and quality systems.
Serve as the first point of contact for production-related quality queries during labeling and packaging.
Documentation & Review
Review and approve Batch Production Records and GMP documentation supporting daily operations.
Verify data entries and finished product checks before and during production runs.
Compile and review batch records for lots assembled, labeled, and packaged at AOH for final disposition.
Quality Systems Management
Own, review, and approve controlled documents, including SOPs, Work Instructions, and Forms.
Review and approve Deviations, CAPAs, and Change Control records.
Support and participate in internal/external regulatory inspections and self-led site audits.
Continuous Improvement & Leadership
Mentor operations and support staff on quality principles to strengthen site quality culture.
Participate in Lean Transformation and Operational Excellence initiatives.
Support site EHSS (Environment, Health, Safety & Sustainability) goals by maintaining a safe workplace.
Qualifications
Basic Qualifications
High School Diploma/GED + 4 years of Quality and/or GMP Manufacturing experience, OR
Associate’s Degree + 2 years of Quality and/or GMP Manufacturing experience, OR
Bachelor’s Degree + 6 months of Quality and/or GMP Manufacturing experience, OR
Master’s Degree (no experience required).
Preferred Qualifications
Degree in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies.
Experience in GMP/GCP operations or other regulated manufacturing environments.
Familiarity with digital innovation, data analytics, and Quality Engineering concepts.
Experience with raw material receipt, inspection, and sampling.
Strong communication, organizational, and documentation skills.
Proficiency with ERP systems (SAP), TrackWise, and CDOCS software.
Ability to work independently while managing multiple priorities.
What Amgen Offers
Amgen provides a Total Rewards Plan that includes:
Competitive salary and discretionary annual bonus program.
Retirement & Savings Plan with company contributions.
Comprehensive medical, dental, and vision coverage.
Life and disability insurance, and flexible spending accounts.
Stock-based long-term incentives.
Award-winning paid time-off plans.
Flexible work models, including remote and hybrid options (where applicable).
Career development and learning opportunities to support long-term growth.
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer committed to a diverse, inclusive, and ethical workplace. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected category.
Amgen provides reasonable accommodations for individuals with disabilities during the application, interview, and employment process.
Apply Now: careers.amgen.com
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