Lab Manager

Role Summary

The Lab Manager will be responsible for end-to-end management of the Quality Control Laboratory, ensuring accurate testing, regulatory compliance, and operational excellence. This role involves leading microbiologists and analysts, maintaining compliance with FDA, cGMP, ISO, and customer requirements, and ensuring the integrity, reliability, and timely release of laboratory results. The position combines strong technical expertise with people leadership and cross-functional collaboration.

Key Responsibilities

1. Laboratory Operations & Compliance

• Manage daily QC laboratory operations including microbiological, chemical, and physical testing.
• Ensure full compliance with FDA regulations, cGMP (21 CFR 111/117), ISO 17025, and internal SOPs.
• Maintain audit readiness for customer, regulatory, and third-party inspections.
• Review, approve, and release test results and Certificates of Analysis (COAs).
• Oversee method validation, verification, and method transfers.

2. Team Leadership & People Management

• Lead, mentor, and develop a team of microbiologists and laboratory analysts.
• Allocate workload, manage shifts, and ensure optimal productivity and turnaround time.
• Conduct performance evaluations, training plans, and competency development.
• Foster a culture of quality, accountability, and continuous improvement.

3. Documentation & Data Integrity

• Ensure accurate documentation, recordkeeping, and data integrity in line with ALCOA principles.
• Review and approve SOPs, test methods, deviations, OOS, CAPAs, and change controls.
• Maintain and oversee LIMS usage, ensuring data traceability and compliance.

4. Equipment & Laboratory Infrastructure

• Manage laboratory equipment calibration, qualification, and preventive maintenance.
• Plan and execute procurement, installation, and validation of new laboratory equipment.
• Ensure laboratory safety, hygiene, biosafety, and environmental compliance.

5. Cross-Functional Collaboration

• Work closely with QA, Regulatory Affairs, Procurement, Operations, and Sales teams.
• Support customer technical inquiries, questionnaires, investigations, and audits.
• Assist in supplier qualification, raw material evaluation, and risk assessments.

Qualifications & Experience

Education

• Bachelor’s or Master’s degree in Microbiology, Biotechnology, Chemistry, Food Science, or a related discipline.

Experience

• 7–12 years of relevant laboratory experience.
• Minimum 3–5 years in a laboratory leadership or supervisory role.
• Strong hands-on exposure to microbiological testing including pathogens, yeast & mold, and total plate count (TPC).
• Experience in nutraceuticals, dietary supplements, food, or pharmaceutical industries preferred.

Technical Skills

• FDA cGMP compliance (21 CFR 111/117).
• ISO 17025 / GLP standards.
• Microbiological and analytical testing techniques.
• OOS investigations, CAPA management, and deviation handling.
• LIMS and data integrity systems.

Soft Skills

• Strong leadership and people management capabilities.
• High attention to detail, ethics, and data integrity.
• Excellent problem-solving and decision-making skills.
• Clear communication and technical documentation abilities.

What We Offer

• Competitive compensation and benefits.
• Growth and leadership opportunities in a global organization.
• High-impact role with ownership of laboratory quality systems.
• A culture driven by quality, accountability, and trust.

Job Category: 83

Job Type: Full Time

Job Location: Victorville

Shift: USA Shift