QC Manager

Job Description

Job Description

The Quality Control Manager oversees all laboratory and QC line operations and personnel responsible for testing raw materials, in-process samples, in-line finished goods and finished OTC products, packaging components, and stability studies. This role ensures compliance with FDA cGMP regulations (21 CFR Parts 210, 211 and 700), USP standards, and internal quality procedures to support the release of safe, compliant, and high-quality Cosmetic and OTC drug products.

The Quality Control Manager works under the general direction of Quality Control Director.

Essential Responsibilities

• Manage, train, and develop QC analysts, chemists, Line Inspectors and microbiologists to ensure efficient, compliant operations.
• Schedule and prioritize 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 sets 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. 
• Complete all other additional tasks assigned by supervisor.

Qualifications

To perform this job successfully, an individual must be able to perform each essential responsibility satisfactorily using the skills and abilities outlined in this job description. The requirements listed below are representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Discretion in handling confidential and sensitive matters.
• Strong knowledge of FDA OTC regulations, USP/NF methods, and ICH stability guidelines.

Education, Experience and Licensure

• 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 a supervisory or managerial capacity.
• Strong experience with microbiological testing, method validation/verification, cleaning validation, OOS investigations, and audit preparation/response.