Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
Job DescriptionSupports all Quality Assurance I roles as requiredSupports administrative function by:monitoring quality systems deadlines and reports to management pending and overdue activitiesassisting in Analytical Subcontractor documentation maintenanceassisting with writing, reviewing, and approving Events, CAPA, OOS/OOT, and Change Controlwriting, reviewing, and conducting Quality System, cGMP, and GLP training as requiredSupports Data Reporting by:reviewing, approving, and releasing laboratory datareviewing, creating, and approving Certificates of Analysisreviewing and approving Cumulative Reports, Protocols, Technical Reports and Summariesreviewing and approving MethodsSupports Document Control by:all Quality Assurance I rolesmaintaining all Master Listsmaintaining Control of Specificationsassisting with writing and approving internal documentsSupports Equipment Control by:maintaining identification and calibration labels/cardsreviewing and approving of preventative maintenance, verification, calibration, and qualificationmaintaining records in LIMSinduction and decommissioningSupports Auditing by:performing Internal audits per Standard Operating Proceduresupporting client and regulatory audits as neededSupports Stability as needed by:reviewing and approving Stability Protocolsreviewing Stability Chamber Pull Schedulesreviewing and approving Stability Chamber mappingmonitoring and following up Stability Chamber excursionsSupports Manufacturing as needed by:executing and reviewing batch recordsQuality Assurance inspection and release of cGMP materialsOther functions as assignedQualifications
Required: a minimum of High School Diploma or Equivalent. Preferred Associate’s Degree and/or certifications in laboratory/quality/regulatory
Required: Understanding of FDA requirements and Quality Systems
Preferred: Must have good administrative skills (Microsoft Office Suite, LIMS, QMS)
Preferred: 1 – 2 Years in a laboratory environment.
Preferred: 3+ years of GLP/GMP environment in laboratory operations or QA, or combination of both
Position is full-time, Monday - Friday 8:00am - 5:00pm . Candidates currently living within a commutable distance of Cary, NC are encouraged to apply.
Excellent full time benefits including comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysEurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.