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
• 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
• Assists with drafting Sample Management SOPs
• Recommends/enacts process improvements
• May train new Sample Management Specialists
• 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 build study sample metadata in LIMS
• May prepare sample manifest files for import into electronic sample management systems (eSMS)
• 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

Additional Responsibilities

• Other duties as needed

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
• 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

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

Supervisory Responsibility

• This position has no supervisory responsibilities

Supervision Received

• Infrequent supervision and instructions
• Frequently exercises discretionary authority

Working Environment

• Primarily office environment
• Occasional laboratory environment, including use of personal protective equipment such as safety glasses, lab coats and gloves
• Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
• Potential exposure to biological fluids with possible exposure to infectious organisms (lab)
• Potential exposure to skin and lung irritants, toxic materials, and hazardous waste (lab)
• Exposure to fluctuating temperatures on rare occasions (lab, loading dock)

Physical Demands

• Ability to work in an upright and /or stationary position for up to 8 hours per day
• Ability to access and use a variety of computer software
• Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
• Frequently interacts with others to obtain or relate information to diverse groups
• Requires multiple periods of intense concentration
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab/office equipment
• Frequent mobility needed
• Occasional crouching or stooping, including bending and twisting of upper body and neck
• Occasional light to moderate lifting and carrying (or otherwise moving) objects, including laboratory samples, laboratory equipment, and laptop computer, with a maximum lift of 30 pounds
• Ability to use personal protective equipment and work effectively in freezers as cold as -80°C
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
• Ability to perform under stress and multi-task
• Regular and consistent attendance

Position Type and Expected Hours of Work

• This is a full-time 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