Data Management Specialist

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 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

Minimum 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

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” work hours as published in the BioAgilytix Employee Handbook
• Occasional weekend, holiday, and evening work required