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JOB FUNCTION: Scientific

POSTED: Jul 31, 2020

Our client works within the Biotech industry and is seeking a Quality Assurance Analyst to join their team.

Salary/Hourly Rate:

Up to $25/hr (Depending on experience)

Position Overview:

The Quality Assurance (QA) Analyst will work to ensure that the documentation review performed for the release of tissue and medical devices is according to current Company procedures and in compliance with applicable regulatory requirements.

Responsibilities of the Quality Assurance Analyst:

  • Review release criteria in accordance with current finished good (FG) specifications, in-process finished goods (IFG) specifications, company procedures for tissue and medical devices, and applicable regulatory requirements
  • Identify deviations, discrepancies, or non-conformances associated with the work order
  • Notify the appropriate individuals, complete the necessary documentation, and ensure the deviations, discrepancies, or non-conformances have been resolved before the tissue or medical device units are released
  • Complete appropriate documentation for the rejection of tissue and medical devices when required
  • Print testing result reports from outside laboratories and internal Company laboratories for review and incorporation into the processing record, if applicable
  • Review recorded measurements for tissue and medical devices in accordance with current FG specifications and Company procedures
  • Review packaging and labeling documentation for tissue and medical devices in accordance with current FG specifications, company procedures, and applicable regulatory requirements
  • Review tissue and medical device processing and storage documentation in accordance with current Company procedures and applicable regulatory requirements
  • Interact with all departments to organize, review, and analyze all data pertaining to the release of tissue or medical devices for compliance with current Company Procedures, IFG and FG specifications, and applicable regulatory requirements
  • Release tissue and medical devices to Inventory Control for international and domestic distribution
  • Review rework work orders and ensure the accurate destruction of tissue if required
  • Enter all required data into the Quality Donor Data System (QDDS) and transfer Work-In-Process (WIP) tissue to the appropriate location in QAD
  • Additional duties, as assigned

Qualifications of the Quality Assurance Analyst:

  • 1-3 years of experience in a GMP or FDA regulated industry
  • 3 or more years experience with documentation review, or laboratory testing
  • 3-5 years QA experience in a GMP or FDA regulated industry where Quality functions were performed such as auditing, approval of batch records, and microbiology testing is strongly preferred
  • Strong written and verbal communication skills
  • Data entry, Microsoft Outlook, Word, and Excel proficiency

Education Requirements:

  • High school diploma is required
  • Bachelor’s Degree in medical or life sciences discipline (e.g. Biomedical Engineering, Biology, Physiology) is a plus
  • Medical Technologist licence or ASQ Certification is a plus


  • Atrium Care Package available

All form fields are required.