QA Specialist

About the role

Join Amgen’s mission of serving patients. As a Specialist QA you will be part of the continued expansion of Quality Operations at Amgen Ohio (AOH), supporting the state‑of‑the‑art Final Drug Product (FDP) Plant. You will lead and direct cross‑functional staff as an informed Subject Matter Expert in quality deliverables, applying critical thinking to ensure quality and compliance with GMP regulations for operations and associated processes.

Responsibilities

• Oversight of daily manufacturing operations, development and approval of standard operating procedures, and quality approval of deviations and final batch disposition.
• Evaluate compliance and quality issues, provide recommendations for improvement projects, and assure progress of records to completion.
• Review and approve controlled documents, including SOPs, validation protocols, validation reports, electronic master batch records, etc.
• Provide quality oversight for quality records (deviations/CAPAs, technical change controls, work orders), ensuring adherence to procedural requirements and accurate assessments of partners.
• Drive investigations and resolution of deviations, ensuring timely, thorough, and compliant outcomes.
• Ensure all activities and related documentation for facilities, equipment, materials, and processes align with applicable regulations and Amgen requirements (GMP, GDoc, safety, controls).
• Own quality‑related SOPs, work instructions, forms, and methods; maintain document‑control excellence with periodic reviews.
• Provide quality oversight for manufacturing and be responsible for batch disposition.
• Offer quality and compliance expertise & guidance; agree on strategies related to process lifecycle management.
• Support and represent Quality during audits and inspections; may interact directly with regulatory agencies on‑site.
• Support Lean Transformation and Operational Excellence initiatives.
• Ensure production records and test results are accurate, complete, and inspection‑ready.
• Champion and lead continuous‑improvement initiatives to strengthen quality systems and operational performance.
• Partner cross‑functionally with Manufacturing, QC, Engineering, Supply Chain, and other stakeholders.

Requirements

Basic Qualifications

• Doctorate degree, or
• Master’s degree + 2 years of Quality and/or Manufacturing experience, or
• Bachelor’s degree + 4 years of Quality and/or Manufacturing experience, or
• Associate’s degree + 8 years of Quality and/or Manufacturing experience, or
• High school diploma / GED + 10 years of Quality and/or Manufacturing experience.

Preferred Qualifications

• Master’s or Bachelor’s degree in a science field.
• 5 years of experience in GMP/GCP operations or a similarly regulated industry.
• Affinity with digital innovation, data sciences, and Quality engineering.
• Experience reviewing/approving validation documentation.
• Ability to work autonomously, provide updates to senior management, and identify potential issues.
• Strong problem‑solving skills; experience managing root‑cause analysis and deviation investigations.
• Experience working with dynamic cross‑functional teams and making decisions.
• Strong organizational skills and ability to follow assignments through to completion.
• Leadership capabilities and experience applying GMP requirements in an operational setting.
• Ability to independently interact with various organizational levels, drive tasks to completion, and act as a self‑starter.

Benefits

• Comprehensive employee benefits package, including retirement and savings plan with generous 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.
• Flexible work models where possible.
• Career development opportunities and support for professional and personal growth.

Pay

In addition to a base salary, Amgen offers a Total Rewards Plan that includes health and welfare plans for staff and eligible dependents, financial plans with retirement savings opportunities, work‑life balance initiatives, and career development programs.