JOB DESCRIPTION

Manages the receipt and inventory of samples, and maintains the security, compliance, and confidentiality of the sample storage room

Specific Tasks:
  • Apply knowledge of company SOPs, GLP and GCP regulatory requirements to oversee the receipt, inventory, storage, use, and disposal of study samples, according to company SOPs
  • Apply knowledge of GLP (FDA, EPA and OECD) and GCP regulations as well as 21 CFR Part 11 (electronic records and electronic signatures) as applicable to the work of the department
  • Manages the receipt and inventory of human blood and other biological samples from clients and clinical trial site with detailed confidential client information, clinical trial information, new drug candidate information, patient information
  • Maintains the security, compliance, and confidentiality of the sample storage information and the sample storage room
  • Ensure that all sample information is handled with the highest level of confidentiality
  • Interact with sponsors and vendors; work with lab personnel, sponsors, and sample sites to identify and resolve sample discrepancies
  • Ensure all instruments within the sample storage are functional, appropriately calibrated, labeled and maintained
  • Explain sample management procedure during client or regulatory agency inspections and audit

Qualifications:

  • High school diploma required ideally Associates or Bachelor of Science 
  • Must have experience with GLP 
  • Ability to work onsite Monday-Friday in Malvern, PA

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