Shift Timing/ Schedule: (Day Shift: 7am-7pm EST OR Night Shift: 7pm-7am EST) Work 2,2,3 Schedule (Alternate Weeks)
Job Description:
Provide oversight of the QA floor program and supervision of processes and personnel.
Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines; build effective teams that apply their diverse skills and perspectives to achieve common goals; oversee daily activity for the group to ensure quality results Performance management for direct reports.
Provide QA oversight, technical expertise and leadership across all aspects of product manufacturing and operations support; develop and update relevant procedures; monitor, participate and oversee the real time batch record review process, including escalation of issues while on the floor.
Ensure manufacturing compliance with applicable procedures and batch records; review manufacturing shop floor documentation, including logbooks, calibrations, play a key role with resolution of quality investigations and CAPAs.
Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
Partner with manufacturing and key stakeholders to prioritize projects aligning with the quality goals and objectives; ensure quality events are captured, investigated and closed appropriately in the Trackwise system.
Actively participates in training activities, managing their individual training plan; also ensures interaction with other shifts given the 24/7 operations.
Qualifications:
Masters' degree in a Scientific, Engineering or Biotech field with 4+ years' experience in Quality Assurance/ Quality Control/ Manufacturing within biologics, biopharmaceuticals, or a regulated industry OR Bachelor's degree in a Scientific, Engineering or Biotech field with 6years' experience in Quality Assurance/Quality Control/ Manufacturing within biologics, biopharmaceuticals, or a regulated industry.
Familiarity with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs; Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish.
Familiarity with electronic systems, including developing and producing reports using Microsoft products. LIMS, Master Control and Trackwise knowledge.