Sr. Associate Plant QA

Responsibilities

• Provide daily guidance and support to Production staff regarding compliance with SOPs and Work Instructions
• Monitor GMP operations and quality systems in device assembly and packaging areas
• Act as the first point of contact for quality-related production queries during packaging and labeling
• Lead, mentor, and coach Operations personnel on quality matters to drive site quality culture
• Review and approve batch production records, deviations, CAPAs, and change control records
• Perform finished product checks during commercial production runs
• Compile and review batch records for lots assembled, packaged, and labeled to support batch disposition
• Own and approve controlled documents, including SOPs, Work Instructions, and Forms
• Participate in self-led inspections and support internal or external regulatory inspections
• Support Lean Transformation and Operational Excellence initiatives

Requirements

• High school/GED + 4 years of Quality and/or GMP Manufacturing experience
• OR Associate’s degree + 2 years of Quality and/or GMP Manufacturing experience
• OR Bachelor’s degree + 6 months of Quality and/or GMP Manufacturing experience
• OR Master's degree
• Knowledge of GMP/GCP operations or similarly regulated industry

Preferred Qualifications

• Scientific degree in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies
• Experience with raw material receipt, inspection, and sampling
• Direct experience with Enterprise Resource Management software such as SAP, TrackWise, or CDOCS
• Strong attention to detail and high degree of accuracy in GMP documentation
• Excellent verbal and written communication skills

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 serving patients living with serious illnesses. Since 1980, Amgen has pioneered the biotech industry, focusing on therapeutic areas including Oncology, Inflammation, General Medicine, and Rare Disease to deliver innovative medicines worldwide.