Amgen · 3 days ago
Specialist Quality Control
West Greenwich, RI
Full-time
Onsite
Mid, Senior Level
4+ years expAmgen is a leading biotechnology company focused on serving patients with serious illnesses. The Specialist Quality Control role involves completing and reviewing analytical testing in a cGMP laboratory, ensuring compliance with safety guidelines and regulatory requirements while supporting quality initiatives.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Follow safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements
Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks
Ensures that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations
Operate laboratory equipment and instrumentation
Performs review and approval of assays, documents and records
Supports Continual Improvement initiatives
Alerts management of quality, compliance, supply and safety risks
Participate in laboratory investigations
Perform general laboratory housekeeping activities
Completes required assigned training to permit carry through of required tasks
Performs additional duties as specified by management
Qualification
Required
High school diploma / GED and 10 years of Quality or Operations experience OR
Associate's degree and 8 years of Quality or Operations experience OR
Bachelor's degree and 4 years of Quality or Operations experience OR
Master's degree and 2 years of Quality or Operations experience OR
Doctorate degree
Preferred
Experience leading teams, projects, or programs
Experience performing analytical testing per Methods
Experience with QC analytical systems and/or Quality systems
Excellent interpersonal, written and verbal communication skills with all levels within the organization
Ability to work in a team matrix environment and build relationships with partners
Identify, manage, and champion innovative projects to advance productivity and enable LEAN principles across different functions
Experience in auditing and defending processes, procedures and decisions during regulatory inspections
Strong leadership and negotiation skills with a demonstrated ability to influence different styles
Demonstrated innovative thinking and ability to transform work organizations
Strong technical writing skills within a highly regulated environment
Exposure to Operational Excellence initiatives
Demonstrated ability to navigate through ambiguity and provide a structured problem solving
Demonstrated ability to coordinate multi-functional project teams and deliver on schedule
Analytical testing experience in the following technologies: HPLC/UPLC (Glycan, Peptide, SEC, CEX, HIC, and/or Titer), Capillary Electrophoresis (CE SDS, cIEF, and/or cOligo), and/or general chemistry testing including UV, Osmolality, pH, polysorbate, subvisible particles, appearance, color and clarity
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, and 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.
10001+ employees
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
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
Recent News
Sports Business Journal
2026-02-08
Pharma Letter
2026-02-07
Labiotech UG
2026-02-07
Company data provided by crunchbase