Quality Assurance (QA) Supervisor

Exciting Opportunity: MN – Quality Assurance Supervisor in Rochester, MN

Are you a dedicated Quality Assurance professional ready to take the next step in your career? Join a leading pharmaceutical organization as a QA Supervisor and play a pivotal role in ensuring product excellence and regulatory compliance in a dynamic, cGMP-regulated environment. This is your chance to lead a talented QA team, drive continuous improvement, and influence quality initiatives in a collaborative and growth-oriented setting.

What You’ll Do:

• Lead, mentor, and develop a high-performing QA team, fostering a culture of accountability, compliance, and continuous improvement.
• Oversee QA training programs to ensure team proficiency in cGMP requirements and quality systems.
• Set performance objectives, provide coaching, and conduct evaluations to support team growth.
• Oversee investigations of deviations, CAPAs, and OOS results, ensuring timely and effective resolution.
• Make informed decisions on product quality and regulatory compliance, escalating risks as needed.
• Manage customer complaint processes to uphold product integrity.
• Review and approve SOPs, methods, batch records, reports, and protocols supporting cGMP activities.
• Support internal and external audits, regulatory inspections, and supplier audits, including documentation and response management.
• Assist in maintaining and enhancing the Supplier Management Program.
• Contribute to the ongoing development of the Quality Management System through SOP improvements, training, and process enhancements.

Required Skills:

• Bachelor’s degree in a scientific discipline.
• 5+ years of Quality Assurance experience within the pharmaceutical industry.
• 2+ years of leadership or supervisory experience.
• Strong knowledge of quality systems, deviation investigations, CAPA, risk assessments, and compliance standards.
• Experience supporting inspections and audit readiness.
• Familiarity with cGMP regulations, including ICH Q7 and 21 CFR Part 211 (preferred).
• Excellent leadership, communication, and technical writing skills.
• Ability to independently manage multiple priorities and lead projects effectively.
• High attention to detail and strong problem-solving capabilities.

Nice to Have Skills:

• Experience with regulatory submission processes.
• Experience with software tools related to quality management.
• Previous exposure to manufacturing environments involving airborne particles, fumes, and moderate noise.

Preferred Education and Experience:

• Bachelor’s degree in a scientific field.
• At least 5 years of QA experience in the pharmaceutical sector.
• Leadership experience in a regulated environment.

Other Requirements:

• Occasional travel for training or educational purposes.
• Ability to lift up to 50 pounds and perform standing/walking activities in a manufacturing environment.
• Adaptability to work in an environment with fumes, airborne particles, and moving machinery.

Position Highlights:

• Direct Hire role offering stability and growth potential
• Competitive compensation range: $90,000 – $110,000 annually
• Schedule: Monday–Friday, 8:00 AM–5:00 PM
• Relocation assistance available to support your move

Ready to make a meaningful impact in quality assurance at a pioneering pharmaceutical company? Apply now and take the next step in elevating your career in a role that offers growth, collaboration, and the opportunity to influence industry standards.