Kelly Science, Engineering, Technology & Telecom
Quality Assurance Supervisor
Kelly Science, Engineering, Technology & Telecom, Rochester, Minnesota, us, 55905
Quality Assurance Supervisor - Rochester, MN
Kelly Science & Clinical is seeking a Quality Assurance Supervisor for a pharmaceutical manufacturer in Rochester, MN. The overall responsibility of this role is to oversee the 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, making key decisions on product quality, compliance, and regulatory conformance, and escalating 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
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. Salary: $100,000 - $150,000.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
Industries Pharmaceutical Manufacturing
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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, making key decisions on product quality, compliance, and regulatory conformance, and escalating 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
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. Salary: $100,000 - $150,000.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
Industries Pharmaceutical Manufacturing
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