Specialist Quality Assurance - Environmental Control Program

Responsibilities

• Provide expert technical support and quality leadership for Environmental Monitoring (EM) and contamination control programs.
• Act as a Subject Matter Expert (SME) for complex operational deviations and contamination control investigations.
• Oversee EM programs for manufacturing classified areas, critical utility systems, and site GMP/non-GMP areas.
• Review environmental monitoring data and trend reports, providing expert interpretation of raw data.
• Drive the design and implementation of procedural controls, sampling strategies, and cleaning/sanitation protocols.
• Execute risk assessments to support the sustainability of site Environmental Monitoring programs.
• Serve as the primary site liaison to the Amgen Contamination Control network and represent the site during regulatory audits.
• Apply statistical tools and methodologies to environmental control trending and monitoring analysis.

Requirements

• Doctorate degree OR Master’s + 2 years GMP experience OR Bachelor’s + 4 years GMP experience OR Associate’s + 8 years GMP experience OR HS + 10 years GMP experience.
• Experience in a GMP-regulated industry.
• Proficiency in statistical tools and data analysis.

Preferred Qualifications

• Educational background in Microbiology, Industrial Microbiology, or Life Sciences.
• Experience in sterile biological product manufacturing or parenteral manufacturing operations.
• Expertise in troubleshooting contamination events and proposing compliant solutions.
• Experience with aseptic process validation and/or airflow visualization.
• Strong ability to conduct scientific data gathering, analysis, and reporting of technical documents.

Benefits

• Comprehensive medical, dental, and vision coverage.
• Retirement and Savings Plan with company contributions.
• Discretionary annual bonus program and 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 across oncology, inflammation, general medicine, and rare diseases.