Quality Assurance Manager; OTC Cosmetics

Yoh is hiring a Quality Assurance Manager (OTC Cosmetics)for our client in theOTC/personal care industry. In this role, you will be responsible for overseeing all quality systems and ensuring compliance with FDA,MoCRA, cGMP and OTC regulations and internal quality standards. The Quality Assurance Manager(OTC Cosmetics) will provide leadership in product quality, regulatory compliance, documentation control, audit readiness, and continuous improvement initiatives to ensure all products are manufactured and released in accordance with MoCRA, FDA, USP, and company requirements.

This individual will also assist the Chemist in the revalidation of equitment.

• Manage and maintain the company’s Quality Management System (QMS) in compliance with FDA cGMP regulations (21 CFR Parts 210, 211, 330, and 700), USP standards, and internal policies
• Oversee Change Control, Deviations, CAPA, and OOS/OOT processes to ensure regulatory compliance
• 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 FDA and third-party regulatory audits; prepare responses and manage CAPA implementation
• Review and approve batch production records, analytical data, and Certificates of Analysis prior to material and product release
• Manage lot disposition, rework, reprocessing, QMRs, MDRs, and related quality documentation
• Collaborate cross-functionally with QC, Production, and R&D to resolve manufacturing and testing issues
• Ensure data integrity and compliance with cGMP documentation practices, including controlled documents and records retention
• Develop and deliver cGMP and quality procedure training programs for manufacturing, laboratory, and warehouse personnel
• Support or lead Product Quality Reviews (PQR/APR) and trend analysis activities
• Provide QA oversight during manufacturing, packaging, and labeling operations
• Review and approve validation protocols and reports (equipment, process, cleaning, computer systems)
• Monitor environmental controls and utilities to ensure compliance with applicable standards
• Ensure calibration, preventive maintenance, and qualification of critical equipment are performed and documented
• Stay current with regulatory updates (FDA guidance, USP updates, ICH Q-series) and update quality systems accordingly
• Drive continuous improvement initiatives to enhance compliance, operational efficiency, and product quality

• Bachelor’s degree in Chemistry, Pharmacy, Biology, or related scientific discipline
• 5+ years of Quality Assurance experience in a cGMP OTC manufacturing environment, including 2+ years in a supervisory or managerial capacity
• Quality Management System (QMS) experience in compliance with FDA, MoCRA, cGMP regulations (21 CFR Parts 210, 211, 330, and 700), and USP standards.
• Strong knowledge of FDA and Cosmetic OTC regulations.
• Leadproduct quality, regulatory compliance, documentation control, audit readiness, and continuous improvement initiatives.
• Demonstrated ability to handle confidential and sensitive information with discretion

Estimated Min Rate
: $95000.00

Estimated Max Rate
: $100000.00

• 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

Note:

Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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