Microbiologist III

Quality Control Microbiologist III – Camarillo, CA The Quality Control Microbiologist II performs quality activities in support of product production and releases. The QC Microbiologist performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting testing, trending and reporting results. We proudly offer: Generous benefit options (eligible first day of employment) Paid training, vacation and holidays (vacation accrual begins on first day of employment) Career advancement opportunities Education reimbursement 401K program with matching contributions Learning platform And more! Responsibilities Lead and/or support quality event investigations for out-of-specification (OOS), out-of-trend (OOT) or nonconformance events Perform environmental monitoring of clean rooms (under ISO and EU specifications) Perform and review QC testing (Endotoxin, Bioburden, TOC, Conductivity, Growth Promotion Assay, etc.) for manufacturing, raw materials, in-process materials, intermediates and final product Demonstrate technical proficiency in test procedures and ensure QC activities are carried out using applicable regulatory requirements (FDA, USP, ICH etc.) Participate in audits, client investigations, and project-related activities Lead and/or support activities associated with Change Control, CAPAs, client audit response, work orders, etc. Receive and process samples to meet production/client timelines Read, trend and report environmental, personnel, in-process, raw material, finished product and water bioburden testing results Prepare and send out samples for microbiological identification Ensure QC sample testing (e.g. in-process, lot release, stability, EM, water) and data approval deadlines are met Work closely and collaborate in a team environment with QC Analytical and Quality Assurance, Manufacturing, Technical Services, Materials Receiving, and Research and Development Ensure the successful implementation and execution of new QC methods/procedures and equipment Perform trending of QC data and present information to Management Perform general laboratory housekeeping Author, review, and approve microbiology test results and analytical methods as needed Support Manufacturing with client-specific testing requirements Inspection of media fills Qualifications Bachelor’s Degree in Microbiology or related field Minimum 5+ years’ industry experience in a GMP sterile finish or pharmaceutical cleanroom environment Willing to work flexible hours (nights and weekends), as‑needed Knowledge, Skills And Abilities Proficient in the validation/qualification of lab microbiological techniques Knowledgeable in FDA cGMPs (21 CFR 211); ISO 9001, 13485 and 17025 Knowledgeable in USP Attention to details and following GMP methods and instructions Other Qualifications Must pass a background check Must pass a drug screen May be required to pass Occupational Health Screening May be required to obtain and maintain gowning certification May be required to obtain and maintain media qualification Pay Range: $84,000–$105,600/year Education, experience, location and tenure may be considered along with internal equity when job offers are extended. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer. #J-18808-Ljbffr