Amgen · 6 hours ago
Specialist QA
Amgen is a biotechnology company committed to serving patients living with serious illnesses. In this role, you will provide Quality Assurance support for Quality Control and work cross-functionally to drive continuous improvement and support various Quality Records.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Support analytical records, deviations and CAPA records
Support site audits and inspections and responses to agencies as required
Reporting metrics and trending and provide statistical evaluations of alert levels
Provide recommendations for improvements based on any trends
Author, data verify and approve applicable quality documents
Own site procedures, support site investigations, and support the metric control plan
Contribute to QC systems initiatives and responsibilities including and not limited to LMES qualifications and LIMS templating
Participate and contribute in QC site inspection readiness initiatives
Qualification
Required
High school diploma / GED & 10 years of Quality and/or Manufacturing experience OR
Associate's degree & 8 years of Quality and/or Manufacturing experience OR
Bachelor's degree & 4 years of Quality and/or Manufacturing experience OR
Master's degree & 2 years of Quality and/or Manufacturing experience OR
Doctorate degree
Preferred
Bachelor's Degree
3+ years experience in the biotechnology or pharmaceutical industry
Experienced in TRA, CAPA, Change Control
Strong communication skills (written and oral), facilitation and presentation skills
Strong organizational skills and ability to multi-task
Team oriented
Experienced in leading projects and teams
Owning records and driving task completion under minimal supervision
Benefits
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
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
Flexible work models where possible.
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Recent News
pharmaphorum
2026-02-06
2026-02-06
2026-02-05
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