Company : The Judge Group
Country: United States
Location : Cleveland, Ohio
Post: Fri, 11 Aug 2023 10:34:36 GMT
Expires: Fri, 08 Sep 2023 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
Location: Cleveland, OH
Description: Our client is currently seeking a Supervisor / Sr. Supervisor, Microbiology QC
This job will have the following responsibilities: Serve as the Microbiology expert within Quality Control group; supervise 1 direct report.
Clearly communicate Microbiology objectives and activities to other department leads, including Quality Control, Quality Assurance, Manufacturing, Validation, Facilities, and Supply Chain.
Review and revise standard operating procedures (SOPs) and workflows, develop and implement training.
Oversee and participate in Environmental Monitoring (EM) of the manufacturing suites (clean-rooms), including sampling/plating, reporting, alert levels, and microbe identification.
Oversee and participate in critical process monitoring (CPM) and in glove and gown qualification for QC and manufacturing personnel.
Ensure inventory materials for EM and CPM are properly stocked and released/qualified for QC use, including growth promotion testing for culture media.
Maintain timely reporting of non-viable particulate (NVP) data from air sampling equipment
Work within companys Quality System: author deviations, laboratory investigations, risk assessments, rationale documents, change controls, and corrective action / preventative action (CAPA) plan, and adhere to Good Documentation Practices (GDP)
Proactively identify sterility/microbiology concerns within facilities, equipment or personnel and help determine solutions.
Track and Trend Environmental Monitoring data throughout the year and compile quarterly reports.
Support microbiology testing of raw materials and drug products: membrane filtration sterility testing, endotoxin, gram staining, growth promotion, biological indicator vials (autoclave validation), and additional laboratory techniques, as needed.
Constantly evaluate and improve Microbiology and Environmental Monitoring practices to most closely align procedures with regulatory guidance.
Qualifications & Requirements: Bachelors degree or Masters degree in science and 5 or more years relevant experience in a CRO / CDMO / biotechnology company / pharmaceutical company.
Experience working in a regulated (GLP, GMP, CLIA) environment.
Experience with FDA/EMA regulations.
Glove and Gown / clean room experience preferred.
Maintain a Growth Mindset: receive constructive feedback from peers and manager; be vocal in sharing constructive feedback and insights with the team and manager.
This job and many more are available through The Judge Group. Find us on the web at