Hiring: Lead QC Associate III - Microbiology Company: FUJIFILM Biotechnologies Location: Durham, NC Job Posted Time: 2026-09-12 13:35:13 Target Skills & Keywords : Six Sigma About the job Experience: •4+ years of experience in a CGMP environment •6+ years of experience in a CGMP Microbiology laboratory Required Skills: •Performs complex microbiological testing (e.g., Bioburden, Endotoxin, Culture Purity, and Microbial Identifications) per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches •Reviews technical data, authors routine and periodic laboratory reports (e.g., Environmental Monitoring (EM) trend reports) and contributes to technical documentation and assessments •Supports client audits and regulatory inspections as an assay or method Subject Matter Expert (SME) •Ensures laboratory maintains inspection readiness, data integrity, and Current Good Manufacturing Practice (CGMP) compliance •Partners with management for technical services, such as initiating events (e.g., deviations and non-conformances) within quality systems •Leads laboratory deviations and investigations •Identifies problems, recommends and implements solutions while consulting with management •Leads and participates in project developments from concept through execution, ensuring alignment with organizational goals Qualifications: •Advanced knowledge of aseptic techniques and behaviors •Effective communication, both written and verbal •Advanced technical writing and problem-solving skills •Demonstrated capacity to complete work independently and with minimal supervision •Demonstrated capacity to prioritize and organize work to deliver assignments according to established schedules and deadlines •Demonstrated capacity to effectively collaborate with coworkers and internal clients •In-depth understanding and knowledge of United States Pharmacopeia and European Pharmacopeia •Demonstrated capacity to support audit readiness for the laboratory •Demonstrated capacity to incorporate lean lab and six sigma principles into the work environment •Demonstrated capacity to manage and complete tasks according to a structured plan Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!