Our Gene Therapy client is growing and looking to add a QC Manager to their team! This role will play a major part in the support of our product pipeline; and be responsible for the management and oversight of internal QC operation activities related to sample management/sample submission for internal testing and routine/non-routine testing of in-process, final product, and raw material samples in accordance with Standard Operating. Responsibilities include but not limited to:
- Management of QC staff and ensuring they are in compliance performing day to day tasks and are thoroughly trained updated on current procedures and protocols.
- Work alongside Analytical Development group during technical transfers of assays from qualification to validation.
- Collaborate with Quality Assurance and lead QC investigation that are associated with deviations, out of specifications, and invalid results.
- Assist with the performance/routine/non-routine testing of in-process, final product, raw material samples in accordance with Standard Operating Procedures such as Protein Assays, Q-PCR, Potency Assay, , HPLC, pH, Osmolality, etc.
- Familiar with FDA and EMA regulatory guidance’s and regulations.
- Responsible for new QC laboratory set up and system maintenance.
- Develop protocols for equipment validation, method validation, and establish other systems as needed.
- Review and initiate deviations, change controls and CAPAs for appropriateness, completeness and to meet internal procedures and regulatory expectations.
- Work with external contract testing labs on any outsourced assays.
- Maintain and schedule any routine analytical testing that are due for stability.
- Maintain QC Laboratory equipment and the calibration service dates to maintain compliance.
- Organize and maintain QC reagents, stocks, and any other lab materials needed to perform testing as needed.
- Bachelor’s degree in Biochemistry, Cell & Molecular Biology, Genetics or related discipline
- Minimum 10 years experience working in a GMP environment
- Minimum 3 years experience supervising the execution and qualification/validation of analytical tests
- Extensive experience managing Quality Control operations and activities.
- Experience managing early/Late phase Quality Control, both internal and external, required and experience with late phase Quality preferred.
- Thorough knowledge of QC analytical equipment such as , Flow Cytometry instrumentation , HPLC, FTIR, and various laboratory equipment