Specialist QA

; however, work schedules may be adjusted in the future based on business needs.

• Execute Quality disposition (approval or rejection) of bulk drug substances.
• Provide Quality oversight for clinical and commercial drug substance operations to ensure manufacturing, testing, storage, and distribution activities are conducted in compliance with cGMP, cGLP, and other applicable regulatory requirements.
• Ensure deviations, quality events, and proposed changes that may impact product quality are appropriately identified, assessed, documented, and managed in accordance with established procedures.
• Ensure production records, testing results, facilities, equipment, materials, processes, and procedures comply with cGMP requirements and are maintained in a complete, accurate, and inspection-ready state.
• Collaborate cross-functionally to ensure Quality Management System (QMS) processes are effectively executed and support compliant operations.
• Champion continuous improvement initiatives, programs, and projects to enhance operational efficiency, quality, and compliance.
• Complete all required training and maintain training compliance to support effective execution of assigned responsibilities.
• Support internal and external audits and regulatory inspections, serving as a Quality Unit representative when required.
• Escalate quality, compliance, supply, and safety risks to senior management, as appropriate.
• Provide Quality support and oversight for New Product Introductions (NPI).

• Educational background in Life Sciences and/or Engineering.
• Expertise in Quality Systems, including Deviations (Non‑conformities), CAPA, and Change Control.
• Experience with key electronic systems, such as documentation platforms (e.g., CDOCS), Maximo, TrackWise, LIMS, MES/electronic batch record systems, and SAP.
• Experience in computer systems validation (CSV) or computer systems quality assurance, including consulting‑level technical proficiency.
• Experience with validation of GxP applications, including Validation Master Plans, GxP risk assessments, IQ/OQ/PQ protocols, test scripts, and summary/approval reports.
• Robust knowledge of manufacturing and distribution processes, including QA, QC, and Process Development operations.
• Experience providing Quality support for complex projects involving packaging, inspection, commissioning, qualification, and new drug substances/products.
• Strong organizational skills, with the ability to drive assignments through successful completion.
• Demonstrated leadership, influencing, and negotiation skills, including interactions with regulatory agencies and evaluation of compliance issues.
• Strong communication skills (written and oral), facilitation abilities, and full bilingual proficiency in English and Spanish, with the ability to work independently and effectively across all organizational levels.

As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and an annual site shutdown
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team. careers.amgen.com

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