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Sample Management Specialist

Company: BioAgilytix
Location: Durham
Posted on: June 12, 2021

Job Description:

The Sample Management Specialist is responsible for GxP-compliant processing of incoming and outgoing samples and reference materials.

Essential Responsibilities

  • Accessions samples into LIMS
  • Imports electronic sample data into eSMS
  • Provides timely notification of sample receipt to appropriate client/study personnel as needed
  • Maintains sample chain-of-custody
  • Reviews study sample demographic data to confirm consistency between sample labels, study paperwork, and electronic sample management systems (eSMS)
  • Resolves discrepancies, with responsibility for investigating and correcting sample anomalies
  • Stages samples for testing per schedule/request
  • Checks out pre-test samples and checks in post-test samples
  • Ensures samples are ready for analysis on time via sample accessioning and staging schedules
  • Manages pre- and post-test sample storage
  • Maintains operability of sample storage units (e.g. routine maintenance, temperature monitoring)
  • Ships samples to domestic or international destinations
  • Dispositions samples as directed by client
  • Provides information for QAU, client, or regulatory agency audit reports as needed
  • Generates and maintains records in a GxP compliant manner
  • Assists with drafting sample management SOPs as needed
  • Collects metrics data as needed
  • Recommends process improvements
  • May serve as a trainer for new Sample Management Technicians
  • 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 manage sample-related data as appropriate:
  • Builds study sample metadata in LIMS
  • Prepares sample manifest files for import into eSMS
  • Follows BAL SOPs
  • Other duties as needed

Minimum Acceptable Qualifications


  • High School diploma and not less than six (6) years' experience in a GxP-regulated laboratory or sample management environment; sample management experience preferred


  • 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 four (4) years' experience in a GxP-regulated laboratory or sample management environment; sample management experience preferred
  • Bachelor's degree in biological science or related field

Working Environment

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

Physical Demands

  • Ability to work in an upright and /or stationary position for up to 8 hours per day
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment
  • Frequent mobility needed
  • Occasional crouching or stooping, with frequent bending and twisting of upper body and neck
  • 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 -80C
  • 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
  • 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 may be required

Keywords: BioAgilytix, Durham , Sample Management Specialist, Other , Durham, North Carolina

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