BioAgilytix
  • QC
  • Durham, NC, USA
  • Full Time

Essential Responsibilities

  • GxP-compliant accessioning of all incoming samples and reference material, as well as the outgoing shipment of samples, reagents and reference materials
  • Review study sample demographic data to confirm consistency between the tube labels, study paperwork and electronic sample management systems (eSMS)
  • Resolve discrepancies, with responsibility for investigating and correcting sample anomalies identified in the eSMS system
  • Provide timely notification of sample receipt to appropriate study personnel
  • Adhere to sample accessioning schedules to ensure samples are ready for sample analysis on time.
  • Maintain GxP-compliant, organized and up-to-date study files with respect to sample paperwork/inventories
  • Manage sample freezer inventory
  • Ship samples to domestic or international destinations as required
  • Assist with writing and reviewing standard operating procedures for sample management processes
  • Collect metrics data required to monitor sample management processes
  • Follow QCT SOPs
  • Other duties as needed

Minimum Acceptable Qualifications

Education/Experience:

  • High school diploma with 0-2 years' experience sample management experience in a biotech or pharmaceutical GxP-regulated environment or Associates degree in biological science or related field with less than 2 years experience in a biotech or pharmaceutical GxP-regulated environment
  • Working knowledge of GxP regulations

 Skills:

  • 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
  • Detail oriented and highly organized
  • Excellent oral and written communication skills
  • Proficient in the use of MS Excel and Word
  • Proficient in the use of LIMS and Quality Management software packages
BioAgilytix
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