Data Management Specialist

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.

Generates and maintains records in a GxP-compliant manner Builds study sample metadata in LIMS Prepares sample manifest files for import into electronic sample management systems (eSMS) Resolves discrepancies and updates electronic information Ensures data integrity and traceability Develops/validates SM software solutions Collects and presents metrics data Participates in audits/inspections as appropriate Provides information for QAU, client, or regulatory agency audit reports as needed Trains new Sample Management Specialists Assists with drafting Sample Management SOPs Recommends/enacts process improvements May train new Data Management Specialists as needed May receive samples as needed: Receives shipments into Sample Management Initiates sample chain-of-custody Provides timely notification of sample receipt to client/BPM May ship samples to domestic or international destinations as needed May accession samples as needed: Accessions samples into LIMS Imports electronic sample metadata into eSMS Resolves discrepancies, with responsibility for investigating and correcting sample anomalies Manages pre- and post-test sample storage Pulls samples for testing per schedule/request Checks out pre-test samples and checks in post-test samples Follows BAL SOPs

High School diploma and not less than eight (8) years’ experience in sample management in a biotech or pharmaceutical GxP-regulated environment

Working knowledge of GxP regulations Ability to work in a fast-paced team environment where multiple concurrent projects must be completed in a timely manner Ability to take direction well and multi-task Acute attention to detail and excellent organizational skills Excellent oral and written communication skills Proficiency in MS Excel and Word Proficiency in LIMS and Quality Management software packages

Associate 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 environment Bachelor’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 environment

Infrequent supervision and instructions Frequently exercises discretionary authority

This is a full-time, on-site position Some flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook Occasional weekend, holiday, and evening work required

laptop-ats-crawler v3