At 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 Sample Management Specialist is responsible forGxP-compliant processing of incoming and outgoing samples and reference materials.
\n Accessions samples into LIMSImports electronic sample data into eSMSProvides timely notification of sample receipt to appropriate client/study personnel as neededMaintains sample chain-of-custodyReviews study sample demographic data to confirm consistency between sample labels, study paperwork, and electronic sample management systems (eSMS)Resolves discrepancies, with responsibility for investigating and correcting sample anomaliesStages samples for testing per schedule/requestChecks out pre-test samples and checks in post-test samplesEnsures samples are ready for analysis on time via sample accessioning and staging schedules Manages pre- and post-test sample storageMaintains operability of sample storage units (e.g. routine maintenance, temperature monitoring)Ships samples to domestic or international destinationsDispositions samples as directed by clientProvides information for QAU, client, or regulatory agency audit reports as neededGenerates and maintains records in a GxP compliant mannerAssists with drafting sample management SOPs as neededCollects metrics data as neededRecommends process improvementsMay serve as a trainer for new Sample Management TechniciansMay receive samples as needed:Receives shipments into Sample ManagementInitiates sample chain-of-custodyProvides timely notification of sample receipt to client/BPMMay manage sample-related data as appropriate:Builds study sample metadata in LIMSPrepares sample manifest files for import into eSMSFollows BAL SOPs Minimum Preferred Qualifications: Education/ExperienceHigh School diploma and not less than six (6) years' experience in a GxP-regulated laboratory or sample management environment; sample management experience preferred Minimum 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 packages Preferred CredentialsAssociate degree in biological science or related field and not less than four (4) years' experience in a GxP-regulated laboratory or sample management environment; sample management experience preferredBachelor's degree in biological science or related field Supervision ReceivedInfrequent supervision and instructionsFrequently exercises discretionary authority
\nBENEFITS AND OTHER PERKS
Medical 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 Program
COMMITMENT TO EQUAL OPPORTUNITY
BioAgilytix 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.