QC Sr Associate, Microbiology

QC Senior Associate, Microbiology This role is a vital part of Amgen’s QC microbiology team, responsible for microbial investigations and assessments, microbiological and analytical testing, sample and data management, equipment operation, troubleshooting, and leadership across GMP operations. Responsibilities Perform microbial assessments and associated GMP documentation such as reports, assessments, and SOP revisions. Support microbial and other QC laboratory investigations. Conduct microbiological testing to support GMP operations. Perform microbiological sample and method qualifications including endotoxin, bioburden, microbial identification, qPCR, and other microbiological assays. Test and review data for compendia, non-compendia methods, and routine laboratory procedures. Generate complete, accurate, and concise laboratory documentation using electronic systems (LMES, LIMS, laboratory notebooks). Operate and maintain specialized laboratory equipment and instrumentation. Lead the team to ensure daily/weekly Level and Flow for testing is performed. Maintain general laboratory housekeeping activities and safety inspections. Maintain training compliance and proficiency. Comply with safety guidelines, cGMPs, and other applicable regulatory requirements. Basic Qualifications High school diploma / GED with 4 years of Quality, Microbiology, or Operations experience. Associate’s degree with 2 years of relevant experience. Bachelor’s degree with 6 months of relevant experience. Master’s degree (qualifications may be considered). Preferred Qualifications Professional experience in a fast‑paced, flexible GMP laboratory. Leadership ability for daily/weekly scheduling, routine and non‑routine testing, and equipment troubleshooting. Execution of microbial test methods (bioburden, endotoxin, microbial identification, growth promotion, qPCR, mycoplasma). Supporting Environmental and Clean Utility Monitoring programs. Operation and maintenance experience with laboratory equipment. Generate and revise methods, reports, and SOPs within CDOCs. Proficiency with electronic systems (LIMS, LMES, CIMS, Trackwise, etc.). Generate, update, and close deviations and analytical result assessments in Trackwise. Use of Maximo to update and complete work orders. Lead Operational Excellence initiatives such as Level and Flow, 5S, and Standard Work in testing labs. Strong written and oral communication, project management, presentation skills, and ability to manage priorities. Flexibility and adaptability to support business needs. Benefits Comprehensive employee benefits package including retirement and savings plan contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts. Discretionary annual bonus program or sales‑based incentive plan for field sales representatives. Stock‑based long‑term incentives. Award‑winning time‑off plans. Flexible work models where possible. 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 BioSpace