Specialist Quality Assurance (Biotech)

Location: United States; locations listed include Thousand Oaks, California and Washington, D.C.

Company

Amgen is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Provide quality systems and quality assurance support to the Product Quality and Stability organizations.
• Support clinical and commercial products in collaboration with Product Quality Leaders and Principal Product Quality Leaders.
• Own, review, and approve GMP documentation, including protocols, reports, specifications, in-process controls, annual product reviews, and procedures.
• Execute quality transactions in Veeva CDOCS, TrackWise, change control, deviation, and CAPA systems.
• Support audits, inspections, annual product review management, investigations, and continuous improvement initiatives.
• Collaborate with Supply Chain, Manufacturing, Quality Control, Regulatory, Quality Engineering, International Quality, and Process Development.

Requirements

• Doctorate degree; or a master's degree with 2 years of relevant experience; or a bachelor's degree with 4 years; or an associate degree with 8 years; or a high school diploma/GED with 10 years of Quality, Operations, Scientific, or Manufacturing experience.
• Understanding of pharmaceutical sciences, quality, compliance, and regulatory requirements for biologics and/or synthetic manufacturing and QC testing.
• Knowledge of biopharmaceutical bulk and drug product development, manufacturing, and cGMPs.
• Experience reviewing and approving cGMP documentation and using quality systems such as Veeva and TrackWise.
• Strong investigation, deviation, CAPA, change control, organization, communication, facilitation, and presentation skills.
• Ability to collaborate in a cross-functional matrix environment, manage competing deliverables, and interact with senior management.

Culture & Benefits

• Collaborative, innovative, science-based work environment.
• Health, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Paid time-off plans and career development opportunities.
• Flexible work models where applicable to the work location type.

Hiring process

• Applications are accepted until a sufficient number of applications are received or a candidate is selected.
• Visa sponsorship is not guaranteed.