Microbiologist III
Curia
Summary
The Quality Control Microbiologist III 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.
Job description
Quality Control Microbiologist III – Camarillo, CA
The Quality Control Microbiologist III 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.
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, finish 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 preferred
- Knowledgeable in FDA cGMPs (21 CFR 211); ISO 9001, 13485 and 17025 a plus
- Knowledgeable in USP , , , and
- 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
Requirements
- 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
- Proficient in the validation/qualification of lab microbiological techniques preferred
- Knowledgeable in FDA cGMPs (21 CFR 211); ISO 9001, 13485 and 17025 a plus
- Knowledgeable in USP , , , and
- Attention to details and following GMP methods and instructions
- 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
Benefits
- Health insurance
- Paid training
- Paid vacation
- Paid holidays
- Career advancement opportunities
- Education reimbursement
- 401k matching
- Learning platform
Company overview
Curia is a leading global Contract Development and Manufacturing Organization (CDMO) with over 30 years of experience in the pharmaceutical industry. Headquartered in Albany, New York, the company operates an integrated network of 25 global sites across North America, Europe, and Asia, employing approximately 3,500 professionals. Curia provides comprehensive end-to-end solutions spanning drug discovery, development, and manufacturing services for both small molecules and biologics. Their expertise covers active pharmaceutical ingredient (API) manufacturing, sterile drug product development, analytical testing, and regulatory support. The company specializes in complex areas including high-potency compounds, controlled substances, sterile APIs, and mRNA manufacturing. With state-of-the-art GMP facilities and a strong focus on innovation, Curia partners with pharmaceutical and biotechnology companies to accelerate the development and commercialization of life-changing therapeutics, from early-stage discovery through commercial-scale production.