Senior QA Lab Manager — Infant Formula & Compliance

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

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