Cosmetix West · 5 days ago
SR Quality Assurance Manager
Torrance, CA
Full-time
Onsite
Senior Level
$90K/yr - $100K/yr
5+ years expCosmetix West is seeking a Sr. Quality Assurance Manager to oversee all quality systems and ensure compliance with FDA cGMP regulations and internal policies governing cosmetics OTC drug manufacturing. This role involves managing the Quality Management System, leading audits, and ensuring product quality and compliance with regulatory standards.
Consumer Goods
Responsibilities
Manage and maintain the company’s Quality Management System (QMS) in compliance with cGMP and FDA OTC requirements
Oversee and ensure proper execution of Change Control, Deviations, CAPA (Corrective and Preventive Actions), and OOS/OOT processes
Ensure compliance with FDA, USP, and ICH guidelines applicable to OTC drug products
Maintain and revise SOPs, batch records, and master manufacturing documents
Lead internal audits and coordinate regulatory or customer audits (FDA, third-party, etc.)
Review and approve batch production records, analytical data, and Certificates of Analysis (CoA) prior to release of raw materials, in-process, and finished goods
Ensure all materials and products meet established quality specifications before disposition
Manage lot disposition, rework, and reprocessing decisions according to quality and regulatory standards
Process Questionable Material Reports (QMR), Material Destruction Records (MDR) and Reprocessing Orders (RO) as needed
Collaborate closely with QC, Production, and R&D to address manufacturing or testing issues
Maintain data integrity across all quality-related systems and records
Ensure compliance with cGMP documentation practices, including controlled documents, logbooks, and records retention
Develop and implement training programs on cGMP and quality procedures for manufacturing, laboratory, and warehouse staff
Support or lead Product Quality Reviews (PQRs/APR) and trend analyses
Provide QA oversight during manufacturing, packaging, and labeling operations, ensuring adherence to approved procedures
Review and approve validation protocols and reports (equipment, process, cleaning, and computer systems)
Monitor environmental controls and ensure utilities (e.g., purified water, compressed air) meet applicable standards
Ensure calibration, preventive maintenance, and qualification of critical equipment are performed and documented
Serve as the Secondary QA contact during FDA inspections and third-party audits; prepare and manage audit responses and CAPA implementation
Stay current with regulatory changes (e.g., FDA guidance, USP updates, ICH Q-series) and update quality systems accordingly
Drive continuous improvement initiatives to enhance efficiency, compliance, and product quality
Enforce adherence to safety policies, chemical hygiene, and PPE requirements
Qualification
Required
Manage and maintain the company's Quality Management System (QMS) in compliance with cGMP and FDA OTC requirements
Oversee and ensure proper execution of Change Control, Deviations, CAPA (Corrective and Preventive Actions), and OOS/OOT processes
Ensure compliance with FDA, USP, and ICH guidelines applicable to OTC drug products
Maintain and revise SOPs, batch records, and master manufacturing documents
Lead internal audits and coordinate regulatory or customer audits (FDA, third-party, etc.)
Review and approve batch production records, analytical data, and Certificates of Analysis (CoA) prior to release of raw materials, in-process, and finished goods
Ensure all materials and products meet established quality specifications before disposition
Manage lot disposition, rework, and reprocessing decisions according to quality and regulatory standards
Process Questionable Material Reports (QMR), Material Destruction Records (MDR) and Reprocessing Orders (RO) as needed
Collaborate closely with QC, Production, and R&D to address manufacturing or testing issues
Maintain data integrity across all quality-related systems and records
Ensure compliance with cGMP documentation practices, including controlled documents, logbooks, and records retention
Develop and implement training programs on cGMP and quality procedures for manufacturing, laboratory, and warehouse staff
Support or lead Product Quality Reviews (PQRs/APR) and trend analyses
Provide QA oversight during manufacturing, packaging, and labeling operations, ensuring adherence to approved procedures
Review and approve validation protocols and reports (equipment, process, cleaning, and computer systems)
Monitor environmental controls and ensure utilities (e.g., purified water, compressed air) meet applicable standards
Ensure calibration, preventive maintenance, and qualification of critical equipment are performed and documented
Serve as the Secondary QA contact during FDA inspections and third-party audits; prepare and manage audit responses and CAPA implementation
Stay current with regulatory changes (e.g., FDA guidance, USP updates, ICH Q-series) and update quality systems accordingly
Drive continuous improvement initiatives to enhance efficiency, compliance, and product quality
Enforce adherence to safety policies, chemical hygiene, and PPE requirements
Discretion in handling confidential and sensitive matters
Strong knowledge of FDA OTC regulations, USP/NF methods, and ICH stability guidelines
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
Experience with method validation, OOS investigations, and audit preparation/response
Experience supporting regulatory inspections, cGMP audits, and method or process validation
Company
Cosmetix West
Cosmetix West is to create the industry’s most efficacious products by utilizing the cleanest, most natural ingredients.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase