Senior Quality Specialist: Medical Device

Company DescriptionEurofins 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 Organisation 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 Organisations. It also has a rapidly developing presence in highly specialised 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 decentralised 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 DescriptionJob DescriptionApplies GMP/GLP/ISO IEC 17025 in all areas of responsibility, as appropriatePerform internal quality assurance auditsReview client or agency documents and identify requirements outside our usual practices, communicate to technical operations, assist with implementing appropriate changesPerform review and approval of SOP'sKeep abreast of regulatory or industry quality assurance (QA) requirements, consult with clients or regulatory authorities regarding any special QA requirements they may have, assist technical operations with application and interpretationsProvide information and revision support for updating company publications including quality policy manuals, company web site, and newslettersIdentify and drive system improvements, both within the department and for laboratory operations; determine the most effective way to accomplish a goal or strategy; suggest improvements to maximize quality and productivityDemonstrate skill in using the computer to access information, perform job functions (e.g., spreadsheets, power point), and prepare other reportsPerform data review (analytical, validation, investigations), review for compliance and identify issues, provide options for resolutionReview QC data and non-conformance issues for assigned technical groups, evaluate for trends or patternsInvestigate and document QA, method, and regulatory deficiencies within the lab; take investigation to next level when needed; diagnose and solve problems independentlyImplement and document computer program changes, review computer system documents, provide feedback to meet regulatory and industry expectationsQualificationsQualificationsThe Ideal Candidate would possess:Strong computer, scientific, quality orientation, and organizational skillsExcellent communication (oral and written) and attention to detailAbility to work independently and as part of a team, self-motivation, adaptability, and a positive attitudeAbility to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policiesWord processing, spreadsheets, PowerPoint, and database experiencePrevious GMP, Root Cause Analysis, and technical writing experienceMinimum Qualifications:Bachelor's degree in a science-related field or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)Minimum three years of laboratory experience with knowledge of regulatory requirementsAuthorization to work in the United States indefinitely without restriction or sponsorshipAdditional InformationPosition is Full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed. Candidates currently living within a commutable distance of Lancaster, Pennsylvania 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 holidays#LI-EB1Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.SummaryType: Full-timeFunction: ScienceExperience level: Mid-Senior LevelIndustry: Biotechnology