Quality Control Senior Associate

About the role

Join Amgen’s mission of serving patients. In this vital role, you will support manufacturing and quality control processes to ensure the timely and accurate testing of Amgen products.

Responsibilities

• Sample Plan templating, logging, and compilation of LIMS packets needed to support manufacturing.
• Hosting and participating in cross-functional, cross-site, and external meetings to support internal and external testing.
• Management support of Contract Laboratory testing, including tracking samples, data entry, and issue resolution to ensure testing is completed on time per Quality Agreements and Disposition Due Dates.
• Certificate of Analysis generation and lot tracking for testing that supports disposition of product and raw materials.
• Support Method Transfer and Validation activities in alignment with manufacturing timelines.
• Document management.

Requirements

Basic Qualifications

• High school diploma or GED + 4 years of Quality experience, OR
• Associate’s degree + 2 years of Quality experience, OR
• Bachelor’s degree and 6 months of Quality or Operations experience.
• Master's degree.

Preferred Qualifications

• Professional work experience in a fast-paced, flexible GMP laboratory.
• Ability to generate and revise methods, reports, and SOPs within CDOCs.
• Demonstrated proficiency with electronic systems (LIMS, LMES, CIMS, CDOCS, etc.).
• Ability to generate, update, triage, and close deviations and analytical test result assessments.
• Experience managing and leading Operational Excellence initiatives, including 5S and Standard Work associated with testing labs.
• Strong written and oral communication skills, project management, and presentation abilities.
• Proven ability to manage priorities effectively and adapt to support business needs.

Benefits

Amgen offers a Total Rewards Plan, based on eligibility, which may include:

• 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 sales-based incentive plan for field sales representatives).
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted on the careers site. Actual salary will vary based on relevant skills, experience, and qualifications.