Quality Assurance Specialist; OTC Cosmetics

Job Overview

Yoh is hiring a Quality Assurance Specialist (OTC Cosmetics) 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 an individual 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 Cosmetic Quality Assurance experience in an FDA‑regulated cGMP manufacturing environment
• Direct OTC cosmetic manufacturing experience
• Cosmetics, personal care, topical, skincare, or contract manufacturing experience
• 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
• 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

Estimated Minimum Rate: $80,000.00
Estimated Maximum Rate: $85,000.00

• 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 applicants will receive consideration for…