Quality Control Microbiology, Manager
San Francisco + Competitive Salary + Growth Opportunities!!!
A newly partnered CRO and Clinical stage immuno-oncology company are looking to expand their Quality team in their new location in South San Francisco to assist in the commercialization of cell and gene therapies and vaccines!
Manage, direct, and evaluate microbiological testing activities of the Quality Laboratory to ensure the safety of products and to comply with quality and regulatory requirements. Work independently with teams from GMP Manufacturing, Process Development, Quality Assurance, and Manufacturing Science and Technology (MSAT) to assist GMP Manufacturing facilities.
If you're looking for the step up in your career and have the drive to move forward, then apply for the position of Quality Control Microbiology, Manager today!
Responsibilities
- Provide subject matter expertise to enhancement and management of the environmental and utilities monitoring programs to support the maintenance of utilities and cleanrooms in conjunction with Manufacturing and Facilities to ensure cGMP compliance and state of control.
- Review records from testing and studies performed by QC staff to assure technical appropriateness, accuracy, and completeness and in accordance with the applicable procedures.
- Scheduling day to day operations of testing, personnel and equipment to ensure support of development and clinical manufacturing in the GMP manufacturing facilities.
- Ensure adherence to cGMP practices for operations and testing performed by QC Microbiology group.
- Manage timely generation of the periodic reports for cleanroom environment, utilities, and microbial isolates.
- Implementation and maintenance of quality systems and assures their area of responsibilities comply to those system.
- Oversee and approve investigations related to testing performed by the QC Microbiology group.
- Lead investigations for microbiological excursions and recommend/assist in implementing appropriate corrective actions.
- Supervision of personnel to achieve optimal productivity and proficiency, including setting personnel goals in alignment with department and company objectives.
- Fosters an empowering environment where team members develop innovative solutions that improve performance, gains team support for change
- Establishes expectations for collaboration within the team and models effective collaboration; supports collaborative efforts with other teams and departments and builds strong partnerships that lead to improved results
- Assure staff are appropriately trained to perform their work assignments and responsibilities
- Resolves and/or escalates problems that arise which affect the routine operations within the QC functional group.
- Assure the safety of all staff working within designated spaces, including providing training and oversight of related activities and responding to safety inspections and audits.
The ideal candidates will have:
- Bachelor's Degree in Microbiology, biological sciences, or related field
- 8 years of relevant field experience
- 2 years of Supervisory Experience
- Microbiological testing, environmental control and monitoring
Benefits will include:
- Tuition reimbursement
- LCIO
- Upward mobility
Does this sound like you? Apply today!
