GxP Data Steward — LIMS & Sample Management

BioAgilytix Labs; San Diego (CA); On-site; USD 70,000 - 75,000; Full time

Benefits offered by this job

Medical Insurance

HDHP with HSA/PPO options

401k with Employer Match

Paid Time Off

Parental Leave

Paid Holidays

Job summary

BioAgilytix Labs seeks a detail-oriented Sample/Data Management specialist to uphold GxP standards, manage samples, and maintain accurate records. You’ll ensure data integrity, support audits, and help optimize sample workflows across laboratory and office environments.

The role emphasizes strong attention to detail, multitasking, and collaboration with cross-functional teams in a fast-paced biopharma setting.

Qualifications

• Bachelor’s degree with 4+ years in sample management in GxP environments.
• Associate degree with 6+ years in sample management in GxP environments.
• High School diploma with 8+ years in sample management in GxP environments.

Responsibilities

• Generates and maintains records in a GxP-compliant manner.
• 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 audits and reports.
• Assists with drafting Sample Management SOPs.
• Recommends process improvements.
• May train new Sample Management Specialists.
• May train new Data Management Specialists as needed.
• May receive samples as needed and manage chain-of-custody.
• May ship samples domestically or internationally.
• May build study sample metadata in LIMS.
• May prepare sample manifest files for eSMS import.
• May accession samples in LIMS and import metadata.
• Resolves discrepancies and investigates sample anomalies.
• Manages pre- and post-test storage.
• Pulls samples for testing per schedule/request.
• Checks out/in pre/post-test samples.
• Follows BAL SOPs.

Skills

GxP regulations

Attention to detail

Multi-tasking

Communication skills

MS Excel

MS Word

Education

Bachelor’s degree in biological science or related field

Associate degree in biological science or related field

High School diploma

Tools

LIMS

Quality Management software

Job description

BioAgilytix Labs seeks a detail-oriented Sample/Data Management specialist to uphold GxP standards, manage samples, and maintain accurate records. You’ll ensure data integrity, support audits, and help optimize sample workflows across laboratory and office environments.

The role emphasizes strong attention to detail, multitasking, and collaboration with cross-functional teams in a fast-paced biopharma setting.