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Quality Assurance Specialist - Medical Device Testing

Company: Eurofins
Location: Lancaster
Posted on: August 2, 2020

Job Description:

Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment and pharmaceutical products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA.Group''s key figures (as of March 2019) are approx. 3.8 billion Euros turnover, over 800 laboratories across 47 countries and about 45,000 staff.Job DescriptionEmployee Responsibilities:Applies GMP/GLP/ISO IEC 17025 in all areas of responsibility, as appropriateDemonstrates and promotes the company visionPerform 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 expectationsQualificationsThe 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)At least 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, 8a.m.-5p.m., with overtime as needed.What we Offer: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.by Jobble

Keywords: Eurofins, Lancaster , Quality Assurance Specialist - Medical Device Testing, Healthcare , Lancaster, Pennsylvania

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