Laboratory Manager
Job in
Eau Claire, Eau Claire County, Wisconsin, 54701, USA
Listed on 2026-10-05
Listing for:
Kelly Science, Engineering, Technology & Telecom
Full Time
position Listed on 2026-10-05
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
- 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.
- 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.
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