QC Specialist, Microbiology

QC Specialist, Microbiology What you will do Lead QC Laboratory investigations in microbiology and environmental monitoring Support manufacturing deviation investigations from a microbiology perspective Document microbial assessment reports Revise GMP documents associated with microbiology investigations to support CAPA and Change Controls Support process improvements and other microbiology projects Support the global network for initiatives and projects that impact microbiology groups Support and document trending analysis, validation protocols/reports, and change controls Generate complete, accurate, and concise laboratory documentation using electronic systems (LMES, LIMS, CIMS, laboratory notebooks) Train on assays that support microbial identification activities Operate and maintain specialized laboratory equipment and instrumentation Lead the team to ensure daily and weekly tasks are performed Perform 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 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 Preferred Qualifications Microbiology degree and/or microbiology laboratory experience associated with microbial identification Understanding of manufacturing processes associated with contamination control Professional experience in a fast‑paced, flexible GMP laboratory Leadership ability, support routine and non‑routine testing, method and equipment troubleshooting Ability to generate, investigate, and close deviations and analytical result assessments in Veeva Ability to generate and document validation protocols and reports Ability to evaluate data for trends and document corrective actions Experience performing aliquoting of samples aseptically Operation and maintenance experience with laboratory equipment Ability to generate and revise methods and SOPs within CDOCs Proficiency with electronic systems capturing consumables, testing procedures, results, and investigations (SAP, LIMS, LMES, CIMS, Veeva, etc.) Understanding and use of Maximo (Work Order System) Ability to manage and lead Operational Excellence initiatives including Level and Flow, 5S, and Standard Work Demonstrated written and oral communication skills, project management and presentation skills, and proven ability to manage priorities effectively Flexibility and adaptability to support business needs What you can expect of us The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan that includes: 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 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 (refer to the Work Location Type in the job posting) Application deadline Amgen does not have an application deadline for this position; applications are accepted until a sufficient number of qualified candidates are received or a candidate is selected. 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 provide reasonable accommodation for individuals with disabilities to participate in the application or interview process, to perform essential job functions, and to receive other employment benefits. Please contact us to request accommodation. #J-18808-Ljbffr Amgen SA