GxP Data Management Specialist — LIMS & Sample Ops

BioAgilytix Labs, LLC

Durham (NC)

On-site

USD 65,000 - 95,000

Full time

4 days ago

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Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Flexible Spending Account

Disability Insurance

Paid Time Off

Parental Leave

Paid Holidays

401k

Job summary

BioAgilytix is seeking a Data Management Specialist to handle GxP-compliant data processing within the Sample Management group. The role involves creating and maintaining records, building sample metadata in LIMS, preparing manifest files, and ensuring data integrity across systems.

You will also resolve discrepancies, develop SM software solutions, collect metrics, and assist with audits and training. The position requires strong attention to detail and extensive knowledge of LIMS and QMS

Qualifications

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

Responsibilities

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