Quality Assurance Manager (OTC Cosmetics)

Yoh is hiring a Quality Assurance Manager (OTC Cosmetics) In this role, you will be responsible for overseeing all quality systems and ensuring compliance with FDA, MoCRA, cGMP, and OTC regulations as well as internal quality standards. The Quality Assurance Manager 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 equipment. Job Functions 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 Education, Licensure and/or Experience Bachelor’s degree in Chemistry, Pharmacy, Biology, or a related scientific discipline 5+ years of Quality Assurance experience in a cGMP OTC manufacturing environment, including 2+ years in a supervisory or managerial capacity Experience with a Quality Management System (QMS) compliant with FDA, MoCRA, cGMP regulations (21 CFR Parts 210, 211, 330, 700), and USP standards Strong knowledge of FDA and Cosmetic OTC regulations Lead product quality, regulatory compliance, documentation control, audit readiness, and continuous improvement initiatives Demonstrated ability to handle confidential and sensitive information with discretion Estimated Min Rate $95,000.00 Estimated Max Rate $100,000.00 What’s In It for You? Benefits include: 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) MetLife Voluntary Benefits Employee Assistance Program (EAP) 401(k) Retirement Savings Plan Direct Deposit & weekly e‑payroll 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. Equal Opportunity Employer 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. For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Visit to contact us if you are an individual with a disability and require accommodation in the application process. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice: #J-18808-Ljbffr Yoh Services LLC