Kelly Science, Engineering, Technology & Telecom
Quality Assurance Supervisor (Rochester)
Kelly Science, Engineering, Technology & Telecom, Rochester, Minnesota, United States, 55905
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 Bachelors 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.
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 Bachelors 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.