Sr. Associate Plant QA 12 Hour Day Shift (6am - 6:30pm)

Amgen•New Albany, OH

4d•$82,082 - $111,052

About The Position

Amgen is hiring a Senior Associate Plant QA to provide quality assurance guidance and support to AOH production in a shift-based role. The position performs quality batch record review for commercial batches labeled and packed at AOH and supports other QA-related projects and systems. It works closely with production operators and line leads, shift supervisors, warehouse, facilities, maintenance, and engineering to maintain effective working relationships and support compliant operations. The role includes regular presence in device assembly and packaging areas, oversight of GMP operations and quality systems, review and approval of production documentation, finished-product checks, and preparation of batch records for batch disposition. It also contributes to controlled-document management, deviation/CAPA/change-control review, inspections, Lean Transformation, Operational Excellence, and site safety goals. The stated U.S. annual salary range is $82,081.95–$111,052.05. Amgen describes a Total Rewards Plan, subject to eligibility, with benefits, incentive opportunities, time-off plans, and career development support.

Requirements

High school diploma/GED and 4 years of Quality and/or GMP Manufacturing experience; or an Associate’s degree and 2 years of such experience; or a Bachelor’s degree and 6 months of such experience; or a Master’s degree.
Strong verbal and written communication and interpersonal skills.
Attention to detail and a high degree of accuracy in task execution and GMP documentation.
Ability to complete tasks autonomously, provide updates to senior management, and identify potential issues.
Strong organizational skills, including the ability to follow assignments through to completion.

Nice To Haves

Scientific degree in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies.
Experience in and knowledge of GMP/GCP operations or a similarly regulated industry.
Affinity with digital innovation, data sciences, and Quality engineering.
Experience with raw material receipt, inspection, and sampling.
Direct experience with Enterprise Resource Management software such as SAP, TrackWise, or CDOCS.

Responsibilities

Provide daily guidance to Production staff on compliance with Standard Operating Procedures and Work Instructions.
Maintain regular presence in device assembly and packaging areas to monitor GMP operations and quality systems.
Serve as the first point of contact for quality-related production queries during packaging and labeling operations.
Lead, mentor, and coach Operations and support personnel on quality matters and promote the site Quality culture.
Review and approve batch production records and other GMP documentation in support of daily operations, including data entries before 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 and external regulatory inspections.
Support Lean Transformation and Operational Excellence initiatives.
Follow safety rules and maintain a safe work environment while supporting EHSS corporate and site goals.

Benefits

Health and welfare plans for staff and eligible dependents.
Retirement and Savings Plan with company contributions.
Group medical, dental, and vision coverage.
Life and disability insurance.
Flexible spending accounts.
Discretionary annual bonus program, or sales-based incentive plan for field sales representatives.
Stock-based long-term incentives.
Award-winning time-off plans.
Career development opportunities.
Flexible work models, including remote and hybrid arrangements where possible.