Description

The Analytical Laboratory Manager is responsible for overseeing Quality Control

Laboratory operations supporting Cosmetic and OTC drug products. This role ensures all analytical testing, method validation, stability programs and data integrity practices comply with FDA regulations, cGMPs, USP requirements, and internal quality standards. The position manages laboratory personnel, equipment, and investigations while supporting product release and regulatory readiness.

Requirements

Laboratory Operations

        Manager day-to-day operations of the QC analytical laboratory for raw materials, in-process, finished goods, and stability samples.

        Ensure timely and compliant testing to support batch release for Cosmetic and OTC drug products.

        Establish and maintain laboratory procedures, test methods and specifications.

 Regulatory Compliance

        With Quality Assurance/Regulatory guidance, ensure laboratory compliance with:      

21 CFR 210/211 (OTC drugs)

21 CFR 700 (cosmetics)

USP/NF, ISO 22716 and internal SOPs

Support FDA inspections, audits and regulatory inquiries.

Initiate laboratory investigations, OOS, deviations and CAPAs.

 Method Management

        Oversee method validation, verification and transfer for chemical and physical tests (e.g. assay, impurities, ph, viscosity, preservative content)

        Maintain analytical method lifecycle documentation.

 Stability

        Manage stability programs for OTC products, including protocol generation, data review and expiry dating support.

        Support shelf life extensions with scientific justification where applicable.

Equipment & Systems

        Ensure qualification, calibration and maintenance of laboratory instruments (HPLC, UPLC, GC, UV-Vis, balances, etc.)

        Oversee laboratory systems (Access databases and SYSPRO - ERP)

        Ensure proper handling of reference standards and reagents.

 People Management

        Supervise, train and mentor QC analysts and technicians.

        Ensure staff are trained in cGMPs, safety and laboratory procedures.

 Documentation and Data Integrity

        Review and approve laboratory notebooks, worksheets, electronic data, and reports.

        Participate in SOP authoring and periodic review.