Microbiology Manager

Direct Hire

Responsible for all aspects of QC Microbiology of pharmaceutical manufacturing site. Ensure that all pharmaceutical products meet specific quality standards through the effective evaluation, validation and documentation of activities related to the microbiological aspects of the manufacture and testing of products.

• Responsible for the process, environmental monitoring, training, microbiologist qualification, sampling, microbiology testing, incidence, and investigation in microbiology
• Plan and coordinate QC microbiology priorities by working in collaboration with Microbiology team
• Train employees on aseptic technique, environmental monitoring of the clean rooms and QC Micro test procedures
• Responsible for inspection of aseptic proficiency testing
• Perform routine clean room audits, report findings to management, and support generation of recommendations for process improvement
• Perform root cause analysis and CAPA plan for unplanned deviations in Microbiology area
• Support MFG operations in investigation and CAPA planning for microbiology related unplanned deviations
• Perform routine inspection of in-process and final products
• Review current test methods and required updates for compliance to pharmacopoeia
• Perform QC inspection and process checks/verification
• Represent quality function in manufacturing classified suites during processing
• Direct staff ensuring that all activities are documented, executed, and in compliance with current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLP), ISO Quality Assurance, company policies, standards and procedures
• Perform risk assessment and/or impact assessment of aseptic process
• Other duties as assigned

Qualifications

• Minimum 12 years related experience with minimum 1-2 years related experience in a supervisory role
• BS in Microbiology required
• Strong industry experience in pharmacopoeia testing, sterilization validation and general pharmaceutical microbiology
• Experience with risk assessment of environmental monitoring sampling sites identification
• Work under minimal supervision using Standard Operating Procedures and good judgment to effectively coordinate and execute assigned activities in support of production, Quality Control and Research & Development activities
• Strong verbal, written and interpersonal communication with an emphasis on creating a motivated, effective working team
• Strong organizational skills, the ability to prioritize work and manage multiple tasks independently
• Demonstrated experience conducting investigations, writing protocols, SOP's, validating methods, staff training,
• Strong computer skills and proficient at word processing and utilizing spreadsheets
• Experience in a clean room environment required
• Knowledge of cGMP and GLP, FDA/USP and applicable global regulatory requirements
• Knowledge of microbiology (industrial), environmental monitoring and aseptic techniques
• Experience with sterility testing, Endotoxin assays and validation, microbiological limits testing, knowledge of USP and EP/BP method/validation regulations, Microbiological identification methods