Supervisor, QA (Night Shift)

Job description

This position operates on a night shift 2-2-3 schedule and is eligible for a 15% shift premium. JOB SUMMARY: Oversee the Quality Support (Shop Floor QA) function at KBI Biopharma supporting the manufacture of biopharmaceuticals, providing QA support on the manufacturing floor. Lead the QA-on-the-floor inspection program, review of master and executed batch records, logbooks, room changeovers and room releases. Provide client project support to resolve issues related to GMP manufacturing as needed. Level load work across team in support of batch release dates, daily manufacturing release schedules, and project priorities. Coaches and mentors’ staff. JOB RESPONSIBILITIES: Supervise the Quality Support group supporting GMP manufacturing of bulk drug substance (Biologics). Manage QA oversight of on-going GMP manufacturing activities. Performs QA-on-the-floor inspections. Provides compliance support to manufacturing operators during processing on the floor. Performs QA batch record review of Master and Executed batch records. Provide client project support to resolve issues related to GMP manufacturing as needed. Works directly with Manufacturing Operations to resolve deviations and oth...