This is a direct-hire (permanent) position at our client, and will be fully on-site in Philadelphia, PA.
Schedules and Hours:
Shift A) Sunday to Wednesday from 9:00pm to 8:00am
Shift B) Wednesday to Saturday from 9:00pm to 8:00am
Supervisor, Quality Operations-Nights Shift-Key Points.
- Supervision and Development direct reports, mentoring/coaching to motivate and mentor peers/staff to foster a culture of continuous improvement, quality, and excellence.
- Perform real-time, on-the-floor support for escalations to ensure compliance with GMP and GDP quality initiatives.
- Apply quality compliance theories and principles to independently address a variety of issues of moderate scope. Provide guidance on controlled documents (content, quality, and document lifecycle), identifying gaps, addressing documentation needs, and suggesting process improvements.
- Helps to ensure compliance to cGMPs and facility procedures. Interface with functional groups, such as Manufacturing, Quality Control, and Document Control, to determine events (errors, deficiencies, discrepancies, deviations, and other observations) and escalate if not resolved as appropriate to management.
- Review batch records and related production documentation, ensuring resolution of all identified issues prior product disposition. Work with internal functions to address all identified issues in a timely manner. Reports errors, deficiencies, discrepancies, and observations to management.
- Initiate and participate in standard operating procedure (SOP) revisions to improve compliance.
- Review of Quality System records for compliance.
Requirements
- Minimum B.S. in Biology, Biochemistry, Bioengineering, related technical field, or equivalent industry and technical experience.
- Minimum of 5 years of experience in biopharmaceutical-based GMP aseptic manufacturing. A minimum of 2 years in a Lead/Leadership/Supervisory Role is desired.
- Detailed knowledge of Code of Federal Regulations 21 CFR 210/211 and International Council for Harmonization Guidelines governing current Good Manufacturing
- Experience with use of an electronic QMS, MasterControl.