Quality Control Senior Associate

About the role

At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With a focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Responsibilities

• Support Sample Plan templating, logging, and compilation of LIMS packets needed to support manufacturing.
• Host and participate in cross-functional, cross-site, and external meetings to support internal and external testing.
• Provide management support of Contract Laboratory testing to ensure testing is completed on time per Quality Agreements and Disposition Due Dates, including tracking of samples, data entry, and issue resolution.
• Generate Certificates of Analysis and track lots for testing that supports disposition of product and raw materials.
• Support Method Transfer and Validation activities in alignment with manufacturing timelines.
• Manage document control processes.

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, or
• 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

• Comprehensive employee benefits package, including:
  • Retirement and Savings Plan with generous company contributions
  • Group medical, dental, and vision coverage
  • Life and disability insurance
  • Flexible spending accounts
• 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 several factors, including relevant skills, experience, and qualifications.