Manager, QC Microbiology
3 weeks ago
Salary: $120-130k depending on experience. Responsibilities:
- Supervision of all QC Micro laboratory testing
- Conduct performance management of direct reports and have regular development discussions
- Represent the group in interdepartmental and global meetings
- Sustain environmental monitoring program and on-time release of product lots to patients
- Support the optimization of the aseptic gowning training and qualification program
- Support internal and external audits
- Maintain and support of QC Microbiology Associate training
- Assemble reports on findings from cGMP facility/utilities, as needed. Implement corrective action plans when necessary and frequently update management on environmental trends
- Complete routine record review of test data and related documents for in-process and routine environmental monitoring testing, drug product release. Generation of CoAs for product release
- Develop, revise and review SOPs, qualification/validation protocols and reports
- Support EM/UM excursions investigations as Subject Matter Expert (SME) on EM/UM.
- Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures
- Provide updates at daily and weekly meetings
- Monitor the GMP systems currently in place to ensure compliance with documented policies
- Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
- Gather metric information for use in continuous improvement of areas of responsibility
- Other duties as assigned
- Master’s Degree with 5+ years of experience, Bachelor’s Degree with 7+ years of Microbiology experience, or High School Degree with 11+ years of Microbiology experience
- Demonstrated leadership and management skills, including establishing direction and goals, and building good work ethics for the team
- Minimum of 7 years’ experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is preferred.
- Minimum of 5 years’ experience supervising/managing microbiology and environmental monitoring labs within the biotechnology or pharmaceutical industry
- Experience in the application of microbiological techniques such as air monitoring, water testing, surface monitoring, genus and species identification of various microbes, endotoxin testing and sterility testing of final product.
- Candidate should be well versed in various microbiological techniques including rapid release methods, and qualifying environmental monitoring processes with reference to cell therapy product
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Ability to be flexible with schedule, and work overtime as needed
- Working knowledge of SOP writing and SOP change request is a plus
- Able to follow instructions and SOPs precisely and able to make/keep accurate documentation
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