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Supervisor, Quality Assurance, Microbiology
2 months ago
We are seeking a highly skilled and experienced Supervisor, Quality Assurance, Microbiology to join our team at Iovance Biotherapeutics Inc. The successful candidate will be responsible for overseeing the routine operations and performing testing in the Quality Control Microbiology laboratory.
Key Responsibilities- Oversee Day-to-Day Operations: Ensure the smooth operation of the Quality Control Microbiology laboratory, including the management of personnel, equipment, and supplies.
- Perform Testing and Analysis: Conduct microbiological testing and analysis, including sterility testing, endotoxin testing, media growth promotion, environmental monitoring, plate reading, data review, and microbiology investigations.
- Manage Quality Control Processes: Develop, implement, and maintain quality control processes and procedures to ensure compliance with regulatory requirements and company standards.
- Collaborate with Cross-Functional Teams: Work closely with contract labs, vendors, and other departments to ensure timely and accurate testing and analysis.
- Provide Training and Guidance: Train and guide personnel on microbiological testing and quality control procedures, and provide guidance on quality control processes and procedures.
- Investigate and Resolve Issues: Investigate and resolve issues related to microbiological testing and quality control, including deviations, excursions, and out-of-specification results.
- Education: Bachelor's degree in Biology, Microbiology, or a related scientific field.
- Experience: Minimum five (5) years of experience in a cGMP Quality Control microbiology role, with prior experience in managing a team and having direct reports.
- Skills and Knowledge: High proficiency in aseptic techniques, basic knowledge of Compendial requirements and standards, and proficiency in performing technical writing.
- Physical and Mental Demands: Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), meet requirements for and be able to wear a half-face respirator, and perform physical activities such as standing, walking, and lifting.
- Experience with Cell Therapy Products: Experience with cell therapy products is a plus.
