- 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 5-6 Quality assurance specialists, IPQC technicians 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.
- Maintain Document control process and adherence to periodic review timeline of SOP's.
- Lead cGMP and GDP training for new hires and annual refresher training.
- 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.
- 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.
- Must have at a minimum a bachelor's degree in life sciences.
- Must have at minimum 10-year experience in an FDA regulated environment, pharma, OTC and personal care manufacturing.
- Must have at least 5 years experience in a supervisory role leading and developing teams.
- Must have experience in FDA and 3rd party audits.
- Demonstrated track record in compliance and cGMP requirements.
- Have the ability to multi task and set priorities with minimal supervision.
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Quality Assurance Assistant Manager - Montgomery - VVF IL SERVICES, LLC
Description
The Quality Assurance 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.
About the Role
The QA Supervisor will lead the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in accordance with ISO 22716 and 21 CFR Part 210 & 211, and customers' expectations at the manufacturing site.
Responsibilities
Qualifications
Compensation Range: $90,000 to $120,000
Equal Opportunity Statement
We are committed to diversity and inclusivity in our hiring practices.
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