Kelly Science, Engineering, Technology & Telecom · 6 hours ago
Quality Assurance Supervisor
Kelly Science & Clinical is seeking a Quality Assurance Supervisor for a pharmaceutical manufacturer in Rochester, MN. The role involves overseeing the QA team, managing quality systems, ensuring product quality, and driving continuous improvement initiatives across the organization.
Staffing & Recruiting
Responsibilities
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
Qualification
Required
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
Benefits
Medical
Dental
Vision
Telemedicine
Term life
Whole life
Accident insurance
Critical illness
A legal plan
Short-term disability
Retirement savings plan
Service bonus
Holiday pay plans (earn up to eight paid holidays per benefit year)
Transit spending account
Paid sick leave under the applicable state or local plan
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.