Specialist QA jobs in United States
cer-icon
Apply on Employer Site
company-logo

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
check
Comp. & Benefits
check
H1B Sponsor Likelynote

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

Quality AssuranceQuality ControlCAPAChange ControlBiotechnology experienceStatistical evaluationsCommunication skillsOrganizational skillsTeam orientedProject leadership

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 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 Company
Total Funding
$28.5B
2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO

Leadership Team

leader-logo
Robert Bradway
Chairman and Chief Executive Officer
linkedin
leader-logo
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
linkedin
Company data provided by crunchbase