Laboratory Manager

Kelly Science, Engineering, Technology & Telecom; Eau Claire (WI); On-site; USD 85,000 - 110,000; Full time

Job summary

Kelly Science, Engineering, Technology & Telecom in Eau Claire, WI is seeking a seasoned Quality Assurance leader to oversee QA activities for infant formula manufacturing. You will review batch records, manage product disposition and release, and ensure compliance with FDA regulations and cGMP.

Lead investigations into deviations, perform root-cause analyses, implement CAPA, support audits and inspections, review QA documentation, mentor staff, and collaborate with cross-functional teams to

Qualifications

• Bachelor’s degree in scientific/technical field.
• Minimum five years in a regulated manufacturing environment.
• Experience in infant formula or related industries preferred.
• Leadership or management experience in QA.
• Strong knowledge of cGMP and FDA regs (21 CFR Parts 106 & 107).

Responsibilities

• Oversee QA activities for infant formula manufacturing.
• Ensure compliance with FDA regs and cGMP.
• Lead investigations into deviations and CAPA.
• Perform root-cause analyses and monitor CAPA.
• Support inspections and audits.
• Review and approve QA documentation.
• Collaborate with cross-functional teams to resolve quality issues.
• Monitor quality metrics and drive continuous improvement.
• Train, mentor, and supervise QA staff.
• Serve as key decision-maker for product quality, disposition, and release.
• Maintain QA records per procedures and regulations.
• Promote proactive risk management and regulatory readiness.

Skills

Leadership

Root Cause Analysis

CAPA Management

Audits & Inspections

Regulatory Compliance

Cross-functional Collaboration

Training & Mentoring

Education

Bachelor’s degree in science

Job description

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.