The Quality Control Microbiology Manager is responsible for providing daily management of microbiology lab operations (people, process, product) within Quality Control. The successful candidate will contribute to testing/reviewing QC data, develop environmental and utility monitoring programs and lead QC Microbiology related activities such as investigations, CAPAs and change controls to assure adherence to regulations and client expectations.
HOW YOU WILL MAKE AN IMPACT
- Provide subject matter expertise for and implement Quality Control Microbiology programs, test methods and strategies for newly built cleanrooms in CGT manufacturing facility.
- Lead and provide expertise for growth promotions, and microbial identification.
- Schedule environmental monitoring, utilities, in-process and final product testing including data review/approval.
- Generate, review and/or approved QC Microbiology study protocols and reports for Environmental Monitoring Performance Qualification and Aseptic Qualification.
- Conduct and manage QC Microbiological activities related to risk assessments, deviations, investigations, change controls, CAPAs and audits.
- Select, develop/train, supervise and evaluate microbiology staff to ensure site objectives are met.
- Participate in development and implementation of information technologies that support documentation and data management systems ensuring patient supply.
- Represent QC in cross-functional teams, projects, and GXP-related problem resolution.
1-4 direct reports. May also act as a team lead for facility/client projects.
- Bachelor's Degree in scientific discipline.
- 8+ years of experience in cGMP biotech/pharmaceutical industry.
- Minimum 2 years leadership experience as a manager.
- Thorough knowledge of cGMP/I CH/FDA regulations and IS05, IS07and IS08 environments.
- Clean room and manufacturing environment experience required.
- Experience in design and execution of instrument qualification and validation utilized in QC Microbiology.
- Knowledge of QC Microbiological rapid testing methodologies preferred (e.g. BacT 3D ALERT system).
- Proficient in aseptic technique.
- Ability to independently prioritize/manage activities for self and direct reports.
- Proficient in MS Office applications and information technologies that support documentation and data management systems.