Quality Control Laboratory Manager

A leading, full-service partner at the intersection of product innovation, packaging, and commercial-scale manufacturing, this highly differentiated platform helps customers transform ideas into market-ready products with speed, flexibility, and precision. From initial development through high-volume production, the company offers an integrated solution designed to simplify the path from concept to commercialization.

With broad expertise across health, wellness, nutrition, and healthcare, the platform combines sophisticated manufacturing capabilities with an extensive range of delivery formats. Its breadth of capabilities and flexible infrastructure enable it to serve a diverse customer base while supporting products across a wide range of applications.

They are hiring a QC Laboratory Manager to join their team!

Schedule: 1st shift Mon-Fri 8a-5p

Pay: $95k-$105k

Responsibilities:

• Oversee all Quality Control laboratory activities, including chemical, microbiological, and stability testing, as applicable.
• Ensure timely completion of testing activities to support material disposition, manufacturing operations, product release, and stability programs.
• Maintain laboratory compliance with cGMP requirements, FDA regulations, USP standards, customer requirements, and internal quality systems.
• Ensure laboratory procedures, specifications, test methods, and documentation practices remain current, effective, and compliant.
• Manage laboratory scheduling, staffing, and workload prioritization to meet business objectives and customer commitments.
• Ensure laboratory equipment, instrumentation, and computerized systems are properly qualified, calibrated, maintained, and operating within validated states.
• Lead and approve laboratory investigations, including Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, atypical results, and laboratory errors.
• Review and approve investigations, change controls, risk assessments, method validations, and laboratory-related quality documentation.
• Lead laboratory preparation and participation during regulatory inspections, customer audits, certification audits, and internal audits.
• Monitor key quality indicators (KQIs) to measure laboratory effectiveness, quality, throughput, and compliance.
• Implement identified process improvements that enhance laboratory efficiency, productivity, reliability, and customer service.
• Ensure compliance with ALCOA+ principles and electronic record requirements and data integrity.
• Manage laboratory operating budgets, capital expenditures, staffing plans, and resource allocation.

Requirements:

• Bachelor’s degree in a life sciences field required; Master’s degree preferred
• 5-7 yrs of experience in a quality control laboratory within a regulated industry
• 3-5 yrs of leadership experience in a GMP-regulated laboratory environment
• Strong knowledge of cGMPs, FDA regulations, USP standards, ICH guidelines, and data integrity requirements.
• Experience with chromatography systems, especially HPLC, lab instrumentation, and electronic quality management systems.
• Strong leadership, organizational, project management, and decision-making skills.

We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

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