Quality Control Specialist, Microbiology

Quality Control Specialist, Microbiology In this vital role, you will provide technical and operational leadership for the QC Microbiology and Environmental Monitoring laboratories, leading microbial identification activities, environmental monitoring investigations, and laboratory operations in a highly dynamic, team‑oriented environment. What you will do Lead microbial identification activities, organism assessments, and support routine and non‑routine microbiological testing. Provide leadership for microbiology laboratory operations, coordinate daily priorities, supervise laboratory staff, and support weekend laboratory operations. Own and lead complex microbiological investigations, deviations, environmental monitoring excursions, and contamination events, including root cause analysis, risk assessments, and product impact assessments. Provide technical expertise for environmental monitoring, bioburden control, microbial identification, contamination control strategies, and laboratory controls. Author and drive CAPAs, microbial risk assessments, and change controls to ensure compliant resolution of quality events. Coordinate contract laboratory activities, including testing support, data review, investigation collaboration, and approval of associated documentation. Generate and maintain complete, accurate, and inspection‑ready documentation using electronic laboratory and quality systems (e.g., LMES, LIMS, CIMS, and Veeva). Partner with Quality, Manufacturing, Engineering, and global microbiology teams to support process improvements, operational excellence initiatives, regulatory inspections, and strategic microbiology projects. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a self‑starter with these qualifications. Basic Qualifications High school diploma / GED and 10 years of Quality, Microbiology or Operations experience OR Associates degree and 8 years of Quality, Microbiology or Operations experience OR Bachelors degree and 4 years of Quality, Microbiology or Operations experience OR Masters degree and 2 years of Quality, Microbiology or Operations experience OR Doctorate degree Preferred Qualifications Microbiology degree and/or microbiology laboratory experience associated with microbial identification. Demonstrated leadership experience, including coaching and developing staff, prioritizing laboratory workloads, and supporting routine and non‑routine microbiological testing. Understanding of manufacturing processes associated with contamination control. Experience supporting regulatory inspections and audit readiness activities. Advanced technical writer who can articulate complex events into concise, clear, and contemporaneous documentation that is inspection ready. Professional work experience in a fast‑paced, flexible GMP laboratory. Ability to generate, investigate, triage and close deviations and analytical test result assessments in Veeva. Ability to generate and document validation protocols and reports. Experience performing aliquoting of samples aseptically. Operation, maintenance experience with laboratory equipment. Ability to generate and revise methods and SOPs within CDOCs. Demonstrated proficiency with electronic systems capturing consumables, testing procedures, results, and investigations (SAP, LIMS, LMES, CIMS, Veeva, etc.). Demonstrated understanding and use of Maximo (Work Order System). Ability to manage and lead Operational Excellence initiatives including 5S and Standard Work associated with the testing labs. Demonstrated written and oral communication skills, project management and presentation skills, and proven ability to manage priorities effectively. Demonstrated ability to be flexible and adaptable to support business needs. What you can expect from us We offer a comprehensive Total Rewards Plan, including health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities. This includes: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan. Stock‑based long‑term incentives. Award‑winning time‑off plans. Flexible work models where possible. Sponsorship for this role is not guaranteed. Equal Opportunity Employer Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #J-18808-Ljbffr Initial Therapeutics, Inc.