Laboratory Manager

Quality Assurance Manager- Eau Claire, Wisconsin

Key Responsibilities

• Oversee quality assurance activities related to infant formula manufacturing, including batch record review, product disposition and release, and quality systems management.
• Ensure compliance with applicable FDA regulations, including 21 CFR Parts 106 and 107, cGMP.
• Lead investigations into deviations, nonconformances, complaints, and other quality events.
• Conduct root-cause analyses and develop, implement, and monitor CAPA.
• Conduct internal audits and support FDA, customer, corporate, and other regulatory inspections and audits.
• Review and approve SOPs, change controls, validation and qualification documents, specifications, batch records, and other quality-critical documentation.
• Collaborate with cross-functional teams to resolve quality issues and improve product and process performance.
• Monitor key quality metrics and lead continuous improvement initiatives.
• Train, mentor, and supervise QA personnel while promoting a strong culture of quality and compliance.
• Serve as a key decision-maker for product quality, disposition, and release.
• Ensure QA records are accurate, complete, timely, and maintained in accordance with company procedures and regulatory requirements.
• Promote a proactive approach to risk management, process control, and ongoing regulatory readiness.

Required Qualifications

• Bachelor’s degree in scientific, technical, food science, pharmaceutical science, or related field.
• At least five years of experience in a regulated manufacturing environment.
• Experience in infant formula, food, pharmaceutical, biotechnology, or a related industry preferred.
• Previous leadership, supervisory, or management experience within a quality assurance function.
• Strong knowledge of cGMP requirements, FDA regulations, quality systems, investigations, CAPA, audits, and change control.
• Familiarity with FDA requirements under 21 CFR Parts 106 and 107 strongly preferred.