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EUROFINS BIO DIAGNOSTICS INC GMP Quality Assurance Assoicate in MADISON, Wisconsin

JOB REQUIREMENTS: Company Description Interested in contributingto improving and saving lives? Eurofins Food Chemistry Madison is growing and we\'re looking for amazing team members to join us. In 2021 we moved into a brand new ISO 17025 accredited laboratoryin Madison, WI designed to conductfood chemistry testingspecializing in infant formula, sole-source nutrition products, hemp and CBD, dietary supplements, and a variety of botanicals. Ourtesting portfolio includes vitamins, minerals, contaminants, pesticides and shelf-life studies. We test of a variety of instrumentation including UPLC, HPLC, GC, and LCMS technologies. We offer an innovative and collaborative team environment, and the opportunity to develop expertise on a wide variety of analytical instruments! If you are looking for an opportunity to work for an exciting growth oriented company, we look forward to talking with you! The GMP QA Associate is responsible for supporting the local implementation and operation of the GMP Quality Management System. The role aims to ensure the site remains in a state of GMP compliance providing expert advice relating to GMP and by actively participating in investigations, audits, data reviews, validation projects, and the delivery of GMP related training. Job Description Essential Duties and Responsibilities: * Reviews and approves site quality documents (SOP\'s, Policies, etc.) to ensure compliance with GMP, Eurofins document management procedures and other applicable quality standards * Supports the supplier qualification program by participating in assessments and leading third party audits * Provides regulatory approval of study related documentation (i.e. batch records, protocols, reports, certificates of analysis, etc) prior to release to the Client * Supports the GMP QA internal audit program by scheduling, planning leading, reporting, and following up of system, process and facility audits * Participates in projects to ensure facilities, utilities, equipment and computer systems are appropriately validated/ qualified; approval of key validation deliverables * Deputizes for the GMP QA Manager in Leading the Management Review Process and in hosting client and Regulatory Authority inspections, coordinating the response to observations and follow-up of corrective actions * Represents Eurofins GMP QA at conferences and seminars * Batch review and release/ rejection of Active Pharmaceutical Ingredient (API) * Batch review and release/rejection/recall of US-based Investigational Medicinal Product (IMP) * Supports the GMP QMS, helping to ensure the site-specific requirements are addressed. * Provides review and quality approval of study-related documentation (e.g., protocols, reports, certificates of analysis, methods) prior to release to the client. * Assists in support of the GMP internal audit program by scheduling and conducting internal audits. * Reviews and approves quality events, including deviations, OOS investigations, change controls, and CAPA * Performs other duties as assigned Qualifications To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required. * Bachelor\'s Degree in a Pharmacy, Chemistry or biology related discipline * Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable * 5+ years QA/GMP experience in the pharmaceutical or related industry * In depth knowledge of Good Manufacturing Practice Regulations * Experience of industry quality systems/standards, e.g. ICHQ10, ISO 9000 * Excellent interpersonal/ organizational skills, e.g. communication, decision making, negotiating, problem solving * Experien To view the full job description please use the link below. https://www.aplitrak.com/?adid=YmJnZW5lcmljLjEzMjY5Ljg3NzBAZXVyb2ZpbnN1c2NvbXAuYXBsaXRyYWsuY29t *\ *** APPLICATION INSTRUCTIONS: Apply Online: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjEzMjY5Ljg3NzBAZXVyb2ZpbnN1c2NvbXAuYXBsaXRyYWsuY29t

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