Quality Assurance Supervisor (Rochester)

Quality Assurance Supervisor-Rochester, MN

Kelly Science & Clinical is seeking a Quality Assurance Supervisor for one of our clients, a pharmaceutical manufacturer, in Rochester, MN. The overall responsibility of this role is to oversee the Quality Assurance (QA) team, manage day-to-day operations, support quality-related initiatives, and provide guidance to cross-functional teams,. This role focuses on managing quality systems, ensuring product quality, developing quality team members, and driving continuous improvement initiatives across the organization.

ESSENTIAL JOB FUNCTIONS

• Supervisor and mentor QA team members, fostering accountability, compliance, and continuous improvement
• Oversee QA training, ensuring employees are equipped with GMP and the necessary skills
• Set performance objectives for the QA team and provide regular feedback and performance evaluations
• Provide QA oversight of quality events, deviations, CAPAs, and OOS Phase II investigations, make key decisions on product quality, compliance, and regulatory conformance, and escalate significant risks to leadership
• Oversight of customer complaint handling
• Review and / or approve methods, procedures, master records, executed records, reports, and protocols employed in the conduct of cGMP activities
• Support planning and execution of internal audits, external audits, regulatory inspections, and supplier audits by preparing documentation, maintaining records, and tracking responses to findings.
• Assist in maintaining a Supplier Management Program
• Contribute to the Quality Management System (QMS) by developing, implementing, and continuously improving SOPs, training programs, and systems

REQUIRED EDUCATION / EXPERIENCE

This is a Direct Hire position with pay commensurate upon applicable education and experience. If you feel you meet the above qualifications, please submit your resume for immediate consideration.