JOB REQUIREMENTS: Company Description Interested in contributingtoimproving and saving lives? Eurofins Food Chemistry Madison is growingand we\'re looking for amazing team members to join us. In 2021 we movedinto a brand new ISO 17025 accredited laboratoryin Madison, WI designedto conductfood chemistry testingspecializing in infant formula,sole-source nutrition products, hemp and CBD, dietary supplements, and avariety of botanicals. Ourtesting portfolio includes vitamins, minerals,contaminants, pesticides and shelf-life studies. We test of a variety ofinstrumentation including UPLC, HPLC, GC, and LCMS technologies. Weoffer an innovative and collaborative team environment, and theopportunity to develop expertise on a wide variety of analyticalinstruments! If you are looking for an opportunity to work for anexciting growth oriented company, we look forward to talking with you!The GMP QA Associate is responsible for supporting the localimplementation and operation of the GMP Quality Management System. Therole aims to ensure the site remains in a state of GMP complianceproviding expert advice relating to GMP and by actively participating ininvestigations, audits, data reviews, validation projects, and thedelivery of GMP related training. Job Description Essential Duties andResponsibilities: * Reviews and approves site quality documents(SOP\'s, Policies, etc.) to ensure compliance with GMP, Eurofinsdocument management procedures and other applicable quality standards *Supports the supplier qualification program by participating inassessments and leading third party audits * Provides regulatoryapproval 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, planningleading, reporting, and following up of system, process and facilityaudits * Participates in projects to ensure facilities, utilities,equipment and computer systems are appropriately validated/ qualified;approval of key validation deliverables * Deputizes for the GMP QAManager in Leading the Management Review Process and in hosting clientand Regulatory Authority inspections, coordinating the response toobservations and follow-up of corrective actions * Represents EurofinsGMP QA at conferences and seminars * Batch review and release/rejection of Active Pharmaceutical Ingredient (API) * Batch review andrelease/rejection/recall of US-based Investigational Medicinal Product(IMP) * Supports the GMP QMS, helping to ensure the site-specificrequirements are addressed. * Provides review and quality approval ofstudy-related documentation (e.g., protocols, reports, certificates ofanalysis, methods) prior to release to the client. * Assists in supportof the GMP internal audit program by scheduling and conducting internalaudits. * Reviews and approves quality events, including deviations,OOS investigations, change controls, and CAPA * Performs other dutiesas assigned Qualifications To perform this job successfully, theindividual must be able to perform each essential duty satisfactorily.The requirements below are representative of the knowledge, skill orability required. * Bachelor\'s Degree in a Pharmacy, Chemistry orbiology related discipline * Postgraduate degree (MSC or equivalent) inscience or management related discipline, preferable * 5+ years QA/GMPexperience in the pharmaceutical or related industry * In depthknowledge of Good Manufacturing Practice Regulations * Experience ofindustry quality systems/standards, e.g. ICHQ10, ISO 9000 * Excellentinterpersonal/ organizational skills, e.g. communication, decisionmaking, negotiating, problem solving * Experien To view the full jobdescription please use the link below.https://www.aplitrak.com/?adid=YmJnZW5lcmljLjIxMjU1Ljg3NzBAZXVyb2ZpbnN1c2NvbXAuYXBsaXRyYWsuY29t*\ *** APPLICATION INSTRUCTIONS: Apply Online:https://www.aplitrak.com/?adid=YmJnZW5lcmljLjIxMjU1Ljg3NzBAZXVyb2ZpbnN1c2NvbXAuYXBsaXRyYWsuY29t