GxP Data Steward — Fast-Paced Biotech Data Wizard

BioAgilytix; Durham (NC); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Medical Insurance (HDHP/HSA)

Dental Insurance

Vision Insurance

Flexible Spending Account (medical; D-

Short/Long Term Disability

Paid Time Off (4 weeks)

Parental Leave

Paid Holidays (9 + 5)

401k with Employer Match

Employee Referral Program

Job summary

BioAgilytix is seeking a Data Management Specialist to perform GxP-compliant data processing within the Sample Management group on-site in the United States. You will generate records, build and manage metadata in LIMS, prepare manifest files for eSMS import, and ensure data integrity and traceability across studies.

The role includes participating in audits, training new specialists, and contributing to SOP drafting and process improvements in a fast-paced biotech environment.

Qualifications

• High School diploma and not less than eight (8) years’ experience in sample management in a biotech or pharmaceutical GxP-regulated environment
• Experience in biotech or pharmaceutical GxP-regulated environment required; prior data management exposure preferred
• Proficiency with MS Excel and Word; familiarity with LIMS and QA software is advantageous

Responsibilities

• Generates and maintains records in a GxP-compliant manner
• Builds study sample metadata in LIMS
• Prepares sample manifest files for import into electronic systems
• 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
• Trains new Sample Management Specialists
• Assists with drafting Sample Management SOPs
• Recommends/enacts process improvements
• May train new Data Management Specialists as needed
• Receives shipments into Sample Management
• Initiates sample chain-of-custody
• Provides timely notification of sample receipt to client/BPM
• May ship samples domestically or internationally
• Accessions samples into LIMS
• Imports metadata into eSMS
• Resolves discrepancies and investigates sample anomalies
• Manages pre- and post-test sample storage
• Pulls samples for testing per schedule/request
• Checks out/in samples
• Follows BAL SOPs

Skills

GxP regulations

MS Excel

LIMS

Quality Management software

Communication skills

Multi-tasking

Organizational skills

Education

High School diploma

Associate degree in biological science

Bachelor’s degree in biological science

Tools

None specified

Job description

BioAgilytix is seeking a Data Management Specialist to perform GxP-compliant data processing within the Sample Management group on-site in the United States. You will generate records, build and manage metadata in LIMS, prepare manifest files for eSMS import, and ensure data integrity and traceability across studies.

The role includes participating in audits, training new specialists, and contributing to SOP drafting and process improvements in a fast-paced biotech environment.