QC Specialist, Microbiology

Responsibilities

• Lead QC laboratory investigations regarding microbiology and environmental monitoring
• Support manufacturing deviation investigations from a microbiology perspective
• Document microbial assessment reports and revise GMP documents to support CAPA and Change Controls
• Support process improvements, trending analysis, and validation protocols/reports
• Generate accurate laboratory documentation using electronic systems including LMES, LIMS, CIMS, and Veeva
• Operate and maintain specialized laboratory equipment and instrumentation
• Lead the team to ensure daily and weekly tasks are performed according to safety and cGMP guidelines

Requirements

• High school diploma / GED and 10 years of Quality, Microbiology, or Operations experience
• Associate’s degree and 8 years of Quality, Microbiology, or Operations experience
• Bachelor’s degree and 4 years of Quality, Microbiology, or Operations experience
• Master’s degree and 2 years of Quality, Microbiology, or Operations experience
• Doctorate degree
• Proficiency in electronic systems such as LIMS, LMES, CIMS, and Veeva

Preferred Qualifications

• Microbiology degree and/or laboratory experience associated with microbial identification
• Professional work experience in a fast-paced, flexible GMP laboratory
• Ability to generate, investigate, and close deviations and analytical result assessments in Veeva
• Experience performing aseptic sample aliquoting and laboratory equipment maintenance
• Demonstrated proficiency with SAP and Maximo (Work order System)
• Ability to manage Operational Excellence initiatives such as 5S and Standard Work

Benefits

• Comprehensive employee benefits package including medical, dental, and vision coverage
• Retirement and Savings Plan with generous 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, we have focused on serving patients living with serious illnesses in therapeutic areas such as Oncology, Inflammation, General Medicine, and Rare Disease.