VVF IL SERVICES, LLC · 1 day ago
Quality Assurance & Packaging Quality Supervisor
Montgomery, IL
Full-time
Onsite
Senior Level, Lead/Staff
$90K/yr - $110K/yr
10+ years expVVF IL SERVICES, LLC is a contract manufacturing company specializing in cosmetics and OTC drug products. The QA & Packaging Quality Supervisor is responsible for ensuring the effective deployment of the Quality Assurance program and Quality Management System, driving quality compliance and audit readiness, while managing a team of quality assurance specialists.
Cosmetics
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 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
Qualification
Required
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
Company
VVF IL SERVICES, LLC
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase