Job Description

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

• Bachelor’s degree in a science discipline
• At least 5+ years in a QA function within the pharmaceutical industry, including 2+ years of experience in a leadership role
• Knowledge of cGMPs or quality regulations, including 21 CFR 211 required
• Strong leadership abilities with experience mentoring and developing teams
• Previous experience leading inspection readiness and audits
• Strong knowledge of quality systems, deviation/investigation management, risk assessment, and regulatory compliance expectations

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.

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