Durham, NCSample Management /FT /On-siteAt BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.The Data Management Specialist is responsible for GxP-compliant processing of data within the Sample Management group.Essential ResponsibilitiesGenerates and maintains records in a GxP-compliant mannerBuilds study sample metadata in LIMSPrepares sample manifest files for import into electronic sample management systems (eSMS)Resolves discrepancies and updates electronic informationEnsures data integrity and traceabilityDevelops/validates SM software solutionsCollects and presents metrics dataParticipates in audits/inspections as appropriateProvides information for QAU, client, or regulatory agency audit reports as neededTrains new Sample Management SpecialistsAssists with drafting Sample Management SOPsRecommends/enacts process improvementsMay train new Data Management Specialists as neededMay receive samples as needed:Receives shipments into Sample ManagementInitiates sample chain-of-custodyProvides timely notification of sample receipt to client/BPMMay ship samples to domestic or international destinations as neededMay accession samples as needed:Accessions samples into LIMSImports electronic sample metadata into eSMSResolves discrepancies, with responsibility for investigating and correcting sample anomaliesManages pre- and post-test sample storagePulls samples for testing per schedule/requestChecks out pre-test samples and checks in post-test samplesFollows BAL SOPsMinimum Preferred Qualifications: Education/ExperienceHigh School diploma and not less than eight (8) years’ experience in sample management in a biotech or pharmaceutical GxP-regulated environmentAssociate degree in biological science or related field and not less than six (6) years' experience in sample management in a biotech or pharmaceutical GxP-regulated environmentBachelor's degree in biological science or related field and not less than four (4) years' experience in sample management in a biotech or pharmaceutical GxP-regulated environmentMinimum Preferred Qualifications: SkillsWorking knowledge of GxP regulationsAbility to work in a fast-paced team environment where multiple concurrent projects must be completed in a timely mannerAbility to take direction well and multi-taskAcute attention to detail and excellent organizational skillsExcellent oral and written communication skillsProficiency in MS Excel and WordProficiency in LIMS and Quality Management software packagesPreferred CredentialsAssociate degree in biological science or related field and not less than six (6) years’ experience in sample management in a biotech or pharmaceutical GxP-regulated environmentBachelor’s degree in biological science or related field and not less than four (4) years’ experience in sample management in a biotech or pharmaceutical GxP-regulated environmentSupervision ReceivedInfrequent supervision and instructionsFrequently exercises discretionary authorityPosition Type and Expected Hours of WorkThis is a full-time, on-site positionSome flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee HandbookOccasional weekend, holiday, and evening work requiredBENEFITS AND OTHER PERKSMedical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (9 scheduled; 5 floating), 401k with Employer Match, Employee Referral ProgramCOMMITMENT TO EQUAL OPPORTUNITYBioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.To learn more about how we collect, use, and protect your information, please review our Privacy Policy and Terms of Use.We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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