QC Microbiologist

Job 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.

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.

• 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 elevate 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…