Data Management Specialist

Durham, NCSample Management /FT /On-site

At Bio Agilytix, 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 Responsibilities Generates and maintains records in a GxP-compliant manner

Builds study sample metadata in LIMSPrepares 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 SOPsRecommends/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/BPMMay ship samples to domestic or international destinations as needed

May accession samples as needed:

Accessions samples into LIMSImports electronic sample metadata into eSMSResolves 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 SOPsMinimum

Preferred Qualifications:

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

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

Minimum

Preferred Qualifications:

Skills 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

Preferred Credentials 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

Supervision Received Infrequent supervision and instructions

Frequently exercises discretionary authority

Position Type and Expected Hours of Work This is a full-time, on-site position

Some flexibility in hours is allowed, but the employee must be available during the “core”…