Product Quality Lab Manager

JOB SUMMARY

• The Quality Control Laboratory Manager – Industrial Chemistry (IC) Lab is responsible for leading and managing all Quality Control laboratory activities supporting Cosmetic, OTC Drug, and Nutrition manufacturing operations. This role ensures raw materials, bulk products, standards, and laboratory testing activities are controlled, accurate, compliant, and completed in a timely manner.
• The position is accountable for raw material testing and release, bulk testing and release, standard management and release for Nutrition, Cosmetics, and OTC products, OFA color approval support, color matching, batch adjustment recommendations to Manufacturing, laboratory equipment maintenance and calibration, and overall laboratory compliance with GMP, FDA, and internal Quality System requirements.
• This role serves as the technical and operational leader for the IC Laboratory, ensuring that raw materials and bulk products meet approved specifications and standards before disposition or release. The role also drives improvement in OFA right-first-time performance, bulk approval turnaround time, raw material approval turnaround time, equipment compliance, standards control, laboratory accountability, and sustainable resolution of quality issues.

DUTIES/ RESPONSIBILITIES

•  Lead and manage daily QC laboratory operations for raw material testing, bulk testing, standard management, OFA approvals, color matching, and product release activities.
• Create, review, and approve raw material and bulk dispositions.
• Ensure all raw materials are tested, reviewed, dispositioned, and released within required timelines, including approval within 48 hours where applicable.
• Ensure all bulk products for Cosmetics, OTC, and Nutrition are tested, reviewed, dispositioned, and released against approved specifications and standards, including bulk approval within 48 hours where applicable.
• Ensure raw materials and bulk products meet approved specifications versus current standards before disposition or release.
• Own and manage raw material and bulk standards to ensure standards are current, approved, controlled, properly stored, traceable, and available for testing and release activities.
• Manage standard release activities for Nutrition, Cosmetics, and OTC products, ensuring standards are not expired, missing, incorrect, or misaligned with customer or internal requirements.
• Lead color matching activities for production batches and provide Manufacturing with appropriate color adjustment recommendations when batches require correction.
• Manage OFA color approval activities, including review of customer approval requirements, submission readiness, sample evaluation, status tracking, and follow-up on rejected or delayed approvals.
• Drive improvement in OFA right-first-time performance and support conversion of applicable customers from OFA to in-house approval where appropriate.
• Work closely with Procurement and Warehouse to resolve raw material issues, supplier documentation concerns, receipt issues, and testing/release delays.
• Work with R&D, Manufacturing, Procurement, Planning, QA, suppliers, and customers to address raw material and bulk issues, waivers, deviations, acceptance decisions, specification concerns, and customer requirements.
• Work with R&D on raw material and bulk waivers and acceptance decisions.
• Review supplier specifications, deviations, Certificates of Analysis, and related documentation to support raw material qualification, testing, disposition, and release.
• Create and maintain ingredient specifications based on supplier Certificates of Analysis and approved internal or customer requirements.
• Conduct and/or support raw material risk assessments for recertifications, deviations, supplier issues, and release decisions.
• Manage laboratory equipment readiness, including maintenance, cleaning, calibration, verification, troubleshooting, and documentation.
• Ensure laboratory equipment is maintained and calibrated on schedule and that no testing or release decisions are made using equipment that is overdue, out of calibration, or not verified.
• Manage alert processes for bulk and raw materials.
• Investigate and escalate raw material, bulk, color, OFA, equipment, documentation, and laboratory process issues.
• Identify quality problems or areas for improvement and recommend practical, sustainable solutions.
• Support NCR, deviation, OOS/OOT, CAPA, risk assessment, and customer complaint investigations related to raw materials, bulk, color, testing, standards, or laboratory controls.
• Oversee direct report performance, prioritization, training, accountability, and daily execution.
• Lead the laboratory team with urgency, accountability, and clear expectations to ensure testing, release, documentation, calibration, and standard management activities are completed on time.
• Review and update SOPs, work instructions, forms, flowcharts, and laboratory procedures as needed.
• Ensure laboratory documentation is complete, accurate, traceable, and compliant with GMP documentation practices.
• Ensure the quality of raw materials received and exist in the facility while expediting the testing and release process.
• Report laboratory KPIs during weekly PDCA meetings and monthly scorecards as requested.
• Support internal audits, customer audits, regulatory inspections, and continuous improvement initiatives related to the IC Laboratory.
• Perform additional job duties as assigned.

EDUCATION

• Bachelor’s Degree in Chemistry, Biology, Food Science, Pharmaceutical Science, Engineering, Business, or a related scientific/technical field with 6 years of relevant experience in Cosmetic, OTC, Nutrition, or Bulk Ingredient manufacturing; or

10 years of relevant experience in the manufacture, testing, disposition, and release of Cosmetic, OTC, Nutrition, or Bulk Ingredients.

WORK EXPERIENCE

• Minimum of 6 years of experience in a QC laboratory, cosmetic manufacturing, OTC manufacturing, nutrition manufacturing, personal care manufacturing, or related GMP-regulated manufacturing environment.

• Hands-on experience with color matching, color evaluation, color adjustment recommendations, or bulk shade approval.

• Experience with bulk testing, disposition, and release.

• Experience with raw material testing, disposition, and release.

• Experience managing standards, specifications, supplier Certificates of Analysis, and controlled laboratory documentation.

• Experience supporting or leading laboratory equipment calibration, verification, maintenance, and readiness programs.

• Experience working with Manufacturing, R&D, Procurement, Warehouse, QA, suppliers, and/or customers to resolve quality issues.

• Experience managing, supervising, training, or leading laboratory personnel.

• Cosmetic or personal care manufacturing experience preferred.

• OTC drug manufacturing experience preferred.

• Nutrition or dietary supplement manufacturing experience preferred.

• Contract manufacturing experience preferred.

• Experience with OFA, in-house approval, bulk color approval, or customer standard approval programs preferred.

• Experience with GMP, FDA requirements, GLP, investigations, NCRs, deviations, CAPA, and risk assessments preferred.

• Experience with Oracle, Apex, LIMS, ERP, or electronic quality systems preferred.