QC Manager - Lab Quality & Compliance for OTC/Cosmetics

Cosmetix West

Carson (CA)

On-site

USD 110,000 - 150,000

Full time

5 days ago
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Job summary

Cosmetix West seeks a Quality Control Manager to oversee laboratory and QC operations for testing raw materials, in-process samples, finished goods and stability studies, ensuring FDA cGMP and USP standards compliance.

You will lead a team of QC analysts, chemists, line inspectors and microbiologists, drive method validation, CAPA, and collaborate with QA and Manufacturing to release high-quality cosmetics and OTC products.

Qualifications

  • Bachelor's degree in science (chemistry, pharmacy, or biology) or equivalent work experience.
  • 5+ years Quality Control related experience in a cGMP OTC manufacturing environment, including 2+ years in supervisory capacity.

Responsibilities

  • Manage and develop QC analysts, chemists, line inspectors and microbiologists.
  • Schedule laboratory activities to support production and product release timelines.
  • Provide technical guidance and serve as the primary QC representative in cross‑functional meetings (QA, R&D, Manufacturing).
  • Help develop, implement and maintain QC systems and measures.
  • Communicate quality control information to all relevant organizational departments, outside vendors or contractors.
  • Produce and communicate reports regarding nonconformance of products.
  • Assist in investigations related to Nonconformance or OOS, Customer Complaint etc.
  • Provide Department related data, trends etc. for Management Review.
  • Monitor performance of QC systems to ensure effectiveness, efficiency and compliance to company SOPs and regulatory requirements.
  • Adhere to company policies and procedures and set a positive example for others within the organization.
  • Participate in change control, CAPA, internal audits, and regulatory inspections (FDA, state boards, third‑party auditors).
  • Support method validation/verification, stability program management, and reference standard qualification.
  • Collaborate with QA to ensure timely release of materials and products that meet all quality standards.
  • Ensure laboratory SOPs, test methods, and specifications are up‑to‑date and properly controlled.
  • Assist in updating or writing Department related SOPs and Work Instructions or other Department related documents.
  • Evaluate and implement new analytical technologies, laboratory automation, or process improvements.
  • Enforce adherence to safety policies, chemical hygiene, and PPE requirements.
  • Maintain a clean, organized, and compliant laboratory environment.
  • Develop and conduct training programs for QC personnel on methods, SOPs, and cGMP principles.
  • Resolve production and manufacturing problems to minimize cost and delay.
  • Laboratory and Production: Oversee testing of raw materials, in-process, finished products, water, and stability samples in accordance with compendial (USP, EP, JP) and internal methods.
  • Review and approve laboratory test results, specifications, and Certificates of Analysis (CoA).
  • Update status of Raw Materials, Bulk/Intermediate and Finished Goods in ERP system.
  • Communicate quality control information to all relevant organizational departments, outside vendors or contractors.
  • Ensure accurate execution and documentation of analytical and microbiological testing (e.g., assay, pH, viscosity, microbial limits, identification tests).
  • Ensure environmental monitoring and microbiological controls for production and water
  • Lead or support investigations of Out‑of‑Specification (OOS), Out‑of‑Trend (OOT), and laboratory deviations, including root cause analysis and CAPA implementation.

Skills

FDA OTC regulations
USP/NF methods
ICH stability guidelines
Leadership

Education

Bachelor’s degree in science (chemistry, pharmacy, or biology)

Job description

Cosmetix West seeks a Quality Control Manager to oversee laboratory and QC operations for testing raw materials, in-process samples, finished goods and stability studies, ensuring FDA cGMP and USP standards compliance.

You will lead a team of QC analysts, chemists, line inspectors and microbiologists, drive method validation, CAPA, and collaborate with QA and Manufacturing to release high-quality cosmetics and OTC products.

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