Quality Assurance Specialist; OTC Cosmetics

Quality Assurance Specialist (OTC Cosmetics) (BH-393634-7)

Location:

El Segundo, United States

Sector:
Science & Research

Salary: $80,000.00 to $85,000.00 per annum

Yoh is hiring a Quality Assurance Specialist for our client in the personal care / OTC cosmetics manufacturing industry. In this role, you will support quality systems, documentation, batch record review, SOP development, deviations, CAPA, audit readiness, and cGMP compliance within an FDA-regulated OTC manufacturing environment.

This is a hands‑on QA role ideal for someone with direct OTC/cosmetics manufacturing experience who can write SOPs from scratch, support manufacturing quality activities, and work cross‑functionally with Production, QC, R&D, and Regulatory teams.

• Write, develop, revise, and implement SOPs, work instructions, batch records, and quality documentation from scratch as needed
• Support and maintain Quality Management System (QMS) activities in compliance with FDA cGMP regulations, including 21 CFR Parts 210, 211, 330, and 700
• Support deviations, CAPA, OOS/OOT, nonconformance, and change control processes
• Review batch production records, manufacturing documentation, analytical data, Certificates of Analysis, and related quality records
• Support product release, lot disposition, rework, reprocessing, and related QA documentation
• Provide QA support during manufacturing, compounding, packaging, labeling, and production operations
• Partner cross‑functionally with Production, QC, R&D, Regulatory, Warehouse, and other teams to resolve documentation, manufacturing, and quality issues
• Assist with internal audits, customer audits, FDA inspection readiness, audit responses, and CAPA follow‑up
• Ensure compliance with FDA, USP, ICH, cGMP, GDP, and internal quality standards applicable to OTC drug and cosmetic products
• Support validation documentation and review, including equipment, process, cleaning, and related protocols/reports
• Maintain controlled documents, records, training files, and quality documentation in accordance with cGMP and data integrity requirements
• Develop and deliver training related to SOPs, cGMP, GDP, quality procedures, and manufacturing documentation practices
• Support Product Quality Reviews, trend analysis, quality metrics, and continuous improvement initiatives
• Assist with calibration, preventive maintenance, equipment qualification, and environmental/utility documentation as needed
• Stay current with applicable FDA, USP, ICH, and OTC/cosmetic regulatory requirements and support quality system updates accordingly

• Bachelor’s degree in Chemistry, Biology, Pharmacy, Life Sciences, or related scientific discipline preferred; equivalent relevant experience may be considered
• 3+ years of Quality Assurance experience in an FDA-regulated cGMP manufacturing environment
• Direct OTC manufacturing experience strongly preferred
• Cosmetics, personal care, topical, skincare, or contract manufacturing experience highly preferred
• Hands‑on experience writing SOPs, work instructions, and quality procedures from scratch required
• Experience with deviations, CAPA, OOS/OOT, nonconformance investigations, batch record review, and audit preparation
• Strong understanding of FDA OTC regulations, cGMP, GDP, USP/NF standards, and quality documentation practices
• Experience supporting manufacturing‑floor QA, batch documentation, product release, validation documentation, or inspection readiness preferred
• Strong communication skills and ability to work cross‑functionally with Production, QC, R&D, Regulatory, and Quality teams
• Ability to work in a hands‑on, fast‑paced manufacturing environment with strong attention to detail

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• Met Life Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified…