GxP Data Management Specialist — LIMS Pro

BioAgilytix Labs, LLC; United States; On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical Insurance (HDHP with HSA; PPO)

Dental Insurance

Vision Insurance

Paid Time Off (4 weeks per year)

401k with Employer Match

Job summary

BioAgilytix Labs, LLC is seeking a Data Management Specialist to ensure GxP-compliant processing of data within the Sample Management group. You will generate records, build metadata in LIMS, and prepare manifest files for eSMS integration.

The role entails resolving discrepancies, maintaining data integrity, participating in audits, and training new staff while supporting improvements to SOPs and data workflows in a fast-paced, on-site environment.

Qualifications

• High School diploma with 8+ years in sample management in a biotech or pharmaceutical GxP-regulated environment.
• Knowledge of GxP regulations with hands-on experience in a regulated setting.
• Ability to work in a fast-paced team environment and manage multiple projects.

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.

Skills

GxP regulations

Fast-paced environment

Multi-tasking

Attention to detail

Written communication

MS Excel

LIMS software

Education

Associate degree in biological science

Bachelor’s degree in biological science

Tools

LIMS

Quality Management software

MS Word

MS Excel

Job description

BioAgilytix Labs, LLC is seeking a Data Management Specialist to ensure GxP-compliant processing of data within the Sample Management group. You will generate records, build metadata in LIMS, and prepare manifest files for eSMS integration.

The role entails resolving discrepancies, maintaining data integrity, participating in audits, and training new staff while supporting improvements to SOPs and data workflows in a fast-paced, on-site environment.