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L59-Quality Specialist
2 weeks ago
false false false EN-US X-NONE X-NONE MicrosoftInternetExplorer4 QUALITY SPECIALISTQuality Specialist - Product Release and Audit ComplianceJob Summary:The Quality Specialist - Product Release and Audit Compliance is responsible for ensuring that all OTC drug products and Cosmetic products meet its quality and regulatory requirements prior to release. This role also ensures the site's compliance with internal policies and current Good Manufacturing Practices (cGMP) as outlined by FDA 21 CFR Parts 210 and 211. The incumbent supports internal and external audits, performs batch record reviews, and drives continuous improvement within the quality management system (QMS).Key Responsibilities:1. Product Release: Perform detailed review of executed batch records for completeness, accuracy, and cGMP compliance. Review laboratory data (e.g., COAs, analytical results, stability data) and ensure all specifications are met before product release. Verify label reconciliation and packaging compliance. Collaborate with cross-functional teams (QC, Production, Engineering, Warehouse) to resolve batch-related issues. Ensure timely and compliant release of products for shipment to customers. 2. Audit and Compliance: Prepare for, support, and respond to internal audits, third-party audits, and FDA inspections. Maintain audit readiness across the manufacturing facility by conducting internal self-inspections. Coordinate and track CAPAs, audit findings, and effectiveness checks. Ensure documentation practices align with ALCOA+ principles. 3. Documentation and Record Management: Review and approve SOPs, change controls, deviations, and other GMP-related documentation. Ensure records are properly archived and easily retrievable for audits and inspections. Support electronic and paper-based document control systems. 4. Quality Systems Support: Participate in risk assessments, deviation investigations, and root cause analyses (RCA). Monitor quality metrics and trends related to product release and compliance. Promote continuous improvement initiatives within the QA department and broader operations. Qualifications:Education: Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, or related field) required. Experience: 3 - 5 years of experience in a GMP-regulated environment, preferably in OTC pharmaceutical manufacturing. Direct experience with product release and audit/inspection support is required. Familiarity with FDA regulations (21 CFR 210/211), USP monographs, ICH guidelines, MoCRA, ISO 22716, ISO 9001 etc. Skills: Strong attention to detail and critical thinking. Proficient in documentation review, deviation handling, and CAPA management. Excellent communication and organizational skills. Ability to work independently and manage multiple priorities. Experience with quality systems (e.g., TrackWise, MasterControl) is a plus. Work Environment & Physical Demands: Office, Lab and manufacturing floor setting. Standard work hours with occasional extended hours based on production demands or audits. Note:The above statements shall not be construed as a complete description of all the work requirements.VVF is an equal opportunity employer. We evaluate qualified applicants, without regard to race, color, religion, national origin, sex or gender, age, disability, veteran status, sexual orientation, gender identity or expression, genetic information, including the perception that a person has any of those characteristics or that the person is associated with a person who has, or is perceived to have, any of those characteristics, or any other consideration made unlawful by applicable law. VVF is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please send us an email or call Human Resources and let us know the nature of your request and your contact information.
