On-Site QA Operations Supervisor

Job DetailsJob Location: Scientific Protein Laboratories - Waunakee, WI 53597



Position Summary








Responsible for supervision of the site's QA Operations activities, including on-site inspection of manufacturing and testing operations, on-the-floor (in-process) verification of critical process steps, on-the-floor review of executed batch records, and identification and documentation of deviations. The supervisor is responsible for personnel activities such as: reviews, workload management, scheduling and coordination of training for QA Operations On-Site staff. Schedule is Monday-Friday, 3-11pm.

Essential Responsibilities









Supervise the on-site QA Operations staff and oversee their on-the-floor functions, including but not limited to on-site inspection of manufacturing/testing areas and verification of critical process steps.






Organize the establishment/maintenance of relevant procedures/documents.






Assists all departments in the identification and evaluation of deviations and issues. Assures proper documentation is initiated to capture the event. Organizes communication of issues. Track and trends the issues.






Provide appropriate data and QA support for SPL regulatory functions.






Coordinates/reviews deviations, investigations, change controls and CAPAs






Participates in audits and addresses audit findings where necessary.






Responsible for continuous improvement of SPL cGMP Quality Systems to support on-site QA in compliance with FDA, ICH, USDA, ISPE and other pertinent pharma industry requirements.






Compiles and communicates metrics associated with on-site QA to management as required.






Provide a real-time, on-shift QA presence and point of contact for manufacturing and testing operations, making timely, compliant quality decisions to support continuity of operations.






Perform raw material release in defined situations (e.g., when QA on-site coverage is unavailable), in accordance with applicable procedures.






Perform personnel activities for on-site QA staff, including performance reviews, workload management, shift scheduling and coverage, and coordination of training.






Coordinate shift-to-shift handoff of open quality items between shifts.

Qualifications








Required/Preferred


Qualifications Description




Required


Associate Degree




Preferred


Bachelor's Degree or above

 








Experience








Required/Preferred


Years of Experience


Description




Required


5+ years