Quality Assurance Compliance Specialist

Job Title: Quality Compliance Specialist Job Location: Salt lake City, UT Shift Timings: 08:30 AM - 05:00 PM [Monday to Friday] Job Summary: This position will be responsible for Quality Compliance Oversight, Quality Council Management Review, Site Compliance Metrics, Knowledge Management, Site Inspection Readiness program, Internal Audit program, Partner Management activities, and Supplier Qualification and Vendor Management program. The position is responsible for the development and monitoring of corrective action plans related to trends identified from inspection and audit observations. Job Duties/Responsibilities: Prepare and support communication of site quality system status through management review forums. Manage Quality Technical Agreements (QTA) with internal and external partners to ensure compliance. Lead and execute internal audits to verify adherence to pharmaceutical manufacturing regulations. Coordinate and manage external audits/inspections, including timely responses and CAPA tracking. Oversee Inspection Readiness program to maintain site preparedness. Collaborate with Site Operations and Quality Management to resolve compliance issues promptly. Conduct Knowledge Management activities, including regulatory review and gap assessments. Support investigation reviews and corrective action plans, ensuring proper documentation and notification. Manage vendor/supplier qualification and related compliance activities. Ensure periodic document reviews and gap assessments for department and site compliance. Own and update procedures for assigned responsibilities. Lead special cross-functional projects and present findings to senior management. Complete required training and maintain compliance with all assignments. Maintain work areas and perform duties safely and efficiently in accordance with company policies, cGMPs, SOPs, and Batch Records. Responsible for performing additional related duties as assigned. Job Requirements: Bachelor’s Degree, preferably in a scientific or engineering discipline, or equivalent education/experience with a minimum of 7 years relevant progressive experience in the pharmaceutical or related industry. Strongly prefer a minimum of 3 years performing audits and measurements of GMP Quality Systems, preferably in the pharmaceutical industry. Requires experience and knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems. Working knowledge of FDA, EMA, DEA, EPA and other regulatory requirements for a research and commercial environment. Experience providing support for regulatory agency inspections preferred. Experience with writing and negotiating Quality Technical Agreements preferred. Experience in a pharmaceutical manufacturing environment preferred. Experience with internal/external auditing is preferred. ASQ CQE/CQA Certification (or equivalent) is preferred. Compunnel Inc. is an Equal Employment Opportunity (EEO) employer committed to fostering an inclusive, diverse, and equitable workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, citizenship status, age, disability, protected veteran status, marital status, genetic information, or any other characteristic protected by applicable federal, state, or local law. As a global workforce solutions provider, Compunnel values diversity of thought, background, and experience, and believes an inclusive workforce strengthens innovation and client success. #J-18808-Ljbffr