Senior Associate Quality Assurance

Responsibilities

• Provide daily quality oversight of Drug Product manufacturing areas to ensure alignment with regulatory requirements.
• Maintain a purposeful presence on the manufacturing floor, including Grade 8 clean room gowning.
• Support visual inspection, ASP/AQL performance, and QA oversight assessments.
• Perform electronic batch reviews and review/approve GMP documents (SOPs/Forms).
• Review and approve electronic maintenance documentation, including Work Orders and Job Plans.
• Provide quality support and approval for minor deviations.
• Manage Electronic Batch Record (MES) documentation revisions and approvals.
• Evaluate compliance issues and provide recommendations to ensure quality records are completed.

Requirements

• High school/GED + 4 years of GMP experience OR
• Associate’s degree + 2 years of GMP experience OR
• Bachelor’s degree + 6 months of GMP experience OR
• Master's degree.
• Ability to work flexible shifts, including weekends, on a rotation (Days, Swings, Graves).
• Comfort with clean room gowning requirements in a Grade 8 environment.

Preferred Qualifications

• Bachelor’s Degree in Biochemistry, Biology, Chemistry, or a related science field.
• Demonstrated ability to perform GMP operations, including following detailed SOPs and maintaining good documentation practices.
• Experience managing projects through to completion while meeting timelines.
• Experience working with Quality Systems.
• Strong organizational and communication skills (written and verbal).
• Solid understanding and application of aseptic behaviors and principles.

Benefits

• Comprehensive medical, dental, and vision coverage.
• Retirement and Savings Plan with company contributions.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.

About the Company

Amgen is a leading biotechnology company dedicated to discovering, developing, and manufacturing innovative human therapeutics. Since 1980, Amgen has focused on serving patients living with serious illnesses in therapeutic areas such as Oncology, Inflammation, General Medicine, and Rare Disease.