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Manager of Microbial Quality Assurance
2 months ago
Join the dynamic team at Precigen, Inc., a leader in biopharmaceutical innovation focused on gene and cell therapies. We are currently looking for a Quality Control Microbiology Manager to contribute to our mission of developing advanced treatments for various diseases, including those in immuno-oncology and infectious diseases.
Key Responsibilities:
- Supervise microbial testing procedures and environmental assessments
- Oversee the Environmental Monitoring program to ensure compliance
- Facilitate training initiatives on QC Microbiology and Aseptic Techniques
- Guarantee adherence to Standard Operating Procedures (SOPs) and regulatory standards
- Conduct investigations for Out of Specification (OOS) results and environmental monitoring deviations
- Support interactions with regulatory agencies
- Develop, review, and refine SOPs and validation documentation
- Manage laboratory investigations and address deviations effectively
Qualifications:
- Bachelor's degree with over 8 years of relevant experience or a Master's degree with at least 6 years in Microbiology or a related field
- Proven experience in Environmental Monitoring, Aseptic Process Validation, and QC laboratory management
- In-depth understanding of aseptic techniques, sterile gowning procedures, and cleanroom operations
Essential Skills:
- Strong negotiation and collaboration abilities
- Capability to mentor and develop team members
- Exceptional communication skills
- Flexibility to adapt to changing priorities in a fast-paced environment