Overview The

QA & QMS

Supervisor is responsible for ensuring effective deployment of the Quality Assurance program and Quality Management System within a contract manufacturing environment for cosmetics and OTC drug products. This role ensures all customers and regulatory requirements are consistently met in accordance with

ISO 22716

(Cosmetic GMP), MoCRA and 21 CFR Parts 210 & 211 (cGMP for pharmaceuticals). The successful candidate will serve as a key liaison between internal teams and external customers, driving quality compliance, continuous improvement, and audit readiness across the contract manufacturing plant. Responsibilities Lead the implementation, maintenance, and continuous improvement of Quality Management System (QMS) in accordance with ISO 22716 and 21 CFR Part 210 & 211, and customers' expectations at the manufacturing site. Manage a team of 3-4 Quality assurance specialists, assigning tasks and deliverables. Maintain and manage the annual Site registration Per MoCRA and OTC with the FDA. Update annual product listing with the FDA for cosmetics and OTC products. Author and maintain Annual Product reviews (APR's) for OTC products. Escalation of major non-conformances and customer complaints to Quality head and site leadership. Develop, deploy & sustain a comprehensive Quality Assurance program, by establishing the appropriate policies, standards, procedures, and controls, that ensure reliable supply of quality products consistently, conforming to the established standards, regulatory requirements, and customers' expectations. Act as a key point of contact for customers' quality teams, ensuring all customer-specific requirements and clauses of quality agreements are fulfilled. Be responsible for the end-to-end quality oversight of warehousing, dispensing, compounding, manufacturing, packaging, labelling, releases & shipment of all cosmetics and OTC products produced at the manufacturing site. Review and approve the Master Batch Records, executed batch documentation, QC test reports, deviations, CAPAs, and change controls. Host & manage the internal, customer, regulatory and certification agency audits including preparation, execution, response coordination, and CAPA implementation. Conduct investigations into deviations, complaints, and OOS results; ensure thorough root cause analysis and timely & effective CAPA closure. Deploy effective in-process Quality Assurance checks & measures on the shop floor to sustain the GMP standards and product quality attributes. Ensure ongoing compliance with Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDP) for the plant. Develop and deliver GMP/QMS training to ensure staff remain up to date with quality standards and regulatory changes. Establish suitable processes & controls for new product introduction into plant. Maintain quality metrics, dashboards, and reporting for internal and customer review. Support validation and qualification of equipment, cleaning, and processes in alignment with customer requirements and regulatory guidelines. Implement appropriate vendor management program in accordance with customers' requirements to ensure the quality of incoming materials. Be the custodian of all GXP documents & records, including those that are received from the customers. Experience 5+ years of experience in QA, with at least 2 years in a leadership or supervisory role. Preferred Qualification Successful outcome of Inspections & Audits by the Health Authority (USFDA), 3rd party certification agencies and customers (existing as well as prospective). All finished products released for shipment to the customers meet their established quality standards. Effective & Efficient deployment of Quality Management System ensuring sustained certifications for ISO 22716 and 21 CFR part 210 & 211. Physical Req. Able to stand for long periods of time on the shop floor. Able to sit for long periods of time utilizing a computer. Lifting up to 40lbs on occasion. Education Req. A Bachelor's degree in a related field like engineering, computer science, or business

Pay:

$85,000.00 - $100,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off Vision insurance

Work Location:

In person