Job Title: QC MicrobiologistJob Description
The QC Microbiologist supports microbiological testing, environmental monitoring, quality investigations, and compliance activities within a GMP-regulated manufacturing environment. This role serves as a key microbiology resource for the testing and release of raw materials, packaging components, in-process materials, and finished products while ensuring alignment with regulatory requirements, internal specifications, and quality standards. The QC Microbiologist collaborates closely with cross-functional teams to maintain product quality, support audits and inspections, and drive continuous improvement in contamination control and microbiological practices.
Responsibilities
- Perform microbiological testing of raw materials, packaging components, in-process samples, finished products, and environmental monitoring samples in accordance with approved methods and specifications.
- Conduct microbiological assays for APC, Yeast and Mold, Coliforms, Escherichia coli, Salmonella, Staphylococcus aureus, and other indicator organisms as required.
- Review, interpret, and approve laboratory results to ensure compliance with internal specifications, USP requirements, and applicable regulatory expectations.
- Maintain accurate, complete, and contemporaneous laboratory records, test documentation, and data in accordance with GMP, GLP, GDP, and data integrity guidelines.
- Execute environmental monitoring programs, including viable and non-viable air monitoring, surface monitoring, water monitoring, and personnel monitoring in production and laboratory areas.
- Support cleaning validation, sanitization verification, equipment qualification, and contamination control initiatives by performing appropriate microbiological testing and documentation.
- Conduct ATP testing and microbiological swabbing activities to assess cleanliness and contamination levels of equipment, utilities, and facilities.
- Assist with microbiological risk assessments related to facility modifications, new equipment, process changes, and new product introductions.
- Lead or support investigations involving Out-of-Specification (OOS), atypical, or nonconforming microbiological results, including data review and laboratory assessments.
- Perform root cause analysis and participate in Corrective and Preventive Action (CAPA) activities to address microbiological issues and prevent recurrence.
- Support customer complaint investigations involving microbiological concerns by performing confirmatory testing, data review, and contributing to investigation reports.
- Author, review, and revise standard operating procedures (SOPs), validation protocols, microbiological test methods, trending reports, technical reports, and other controlled quality documents.
- Prepare and analyze microbiological trending reports, including bioburden and environmental monitoring data, and escalate issues when trends indicate potential risk.
- Partner with Quality Assurance, Manufacturing, Sanitation, Operations, and Research and Development teams to support product quality, safety initiatives, and process improvements.
- Provide microbiological expertise during internal, customer, and regulatory audits and inspections, including explanation of methods, results, and quality systems.
- Assist with the development and delivery of GMP, sanitation, and microbiology training for laboratory, production, and quality personnel.
- Utilize LIMS and electronic laboratory systems, where available, to enter, manage, and retrieve microbiological data.
- Ensure adherence to laboratory safety procedures and quality systems while performing routine and non-routine microbiological work.
- Support method validation, verification, and transfer activities, including protocol execution, data analysis, and technical report generation.
- Contribute to continuous improvement initiatives by identifying opportunities to enhance microbiological methods, workflows, and contamination control strategies.
Essential Skills
- Bachelor"s degree in Microbiology, Biology, Biochemistry, or a related scientific discipline.
- Minimum 5 years of experience working in a GMP-regulated microbiology laboratory.
- Hands-on experience performing microbiological testing of raw materials, in-process samples, finished products, and environmental monitoring activities.
- Experience supporting audits and inspections within regulated environments.
- Strong understanding of USP microbiological methods, including USP , USP , USP , and USP .
- Knowledge of FDA regulatory requirements and current Good Manufacturing Practices (cGMP).
- Working knowledge of Good Laboratory Practice (GLP), Good Documentation Practice (GDP), laboratory safety, and quality systems.
- Experience with investigations, including Out-of-Specification (OOS) and nonconforming results, as well as CAPA processes.
- Experience with method validation and verification, including protocol execution and technical report writing.
- Strong analytical and troubleshooting abilities to interpret microbiological data and resolve technical issues.
- Excellent technical writing and documentation skills for SOPs, protocols, reports, and laboratory records.
- Strong attention to detail and organizational skills to manage multiple tests, projects, and documentation requirements.
- Ability to effectively communicate scientific and technical information to cross-functional teams.
- Self-motivated with the ability to prioritize and manage multiple projects in a fast-paced environment.
- Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
- Ability to stand, walk, bend, reach, and perform routine laboratory duties throughout the workday.
- Ability to lift up to 20 pounds occasionally as part of routine laboratory and sampling activities.
- Ability to perform laboratory work requiring close attention to detail and visual accuracy.
Additional Skills & Qualifications
- Experience within dietary supplements, pharmaceuticals, food manufacturing, cosmetics, medical device, or other regulated consumer product industries.
- Familiarity with LIMS and electronic laboratory systems for data entry, management, and reporting.
- Experience generating microbiological trending reports, including bioburden, viable and non-viable particle data, and environmental monitoring results.
- Experience with aseptic technique and working in microbiology laboratories that support GMP manufacturing.
- Knowledge of bioburden testing, viable and non-viable monitoring, swabbing techniques, and ATP testing for contamination assessment.
- Experience contributing to protocol development, test method optimization, and continuous improvement initiatives.
- Demonstrated ability to collaborate effectively with Quality Assurance, Manufacturing, Sanitation, Operations, and R&D teams.
- Strong interpersonal skills and the ability to provide training or guidance in microbiology, GMP, and sanitation practices.
- Interest in ongoing professional development and participation in educational assistance opportunities.
Work Environment
This role operates in a GMP-regulated microbiology laboratory within a contract manufacturing setting that supports regulated consumer products. The QC Microbiologist works primarily in a laboratory environment performing microbiological testing, environmental monitoring, and contamination control activities using equipment such as incubators, biosafety cabinets, environmental monitoring devices, and ATP testing instruments. The position requires frequent standing, walking, bending, and reaching throughout the workday, as well as occasional lifting of up to 20 pounds. Work involves close visual attention to detail when reading culture plates, operating instruments, and documenting data. The environment is fast-paced and highly collaborative, with regular interaction with Quality Assurance, Manufacturing, Sanitation, Operations, and R&D teams. Laboratory work follows GLP, GDP, cGMP, and safety requirements, and may involve the use of LIMS and other electronic laboratory systems. Team members typically wear appropriate laboratory attire and personal protective equipment consistent with GMP and laboratory safety standards. The organization offers a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan, paid time off, life insurance, and professional development and educational assistance opportunities.
Job Type & Location
This is a Permanent position based out of Valencia, CA.
Pay and Benefits
The pay range for this position is $74000.00 - $88000.00/yr.
Benefits Medical, Dental, and Vision Insurance 401(k) Paid Time Off Life Insurance Professional Development and Educational Assistance Opportunities
Workplace Type
This is a fully onsite position in Valencia,CA.
Application Deadline
This position is anticipated to close on Aug 14, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.
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