QA Records Management Analyst

Seeking a QA Records Management Analyst for our client – a leading Biologics company.

  • Maintains the operational attributes & process, confidentiality, effectiveness, efficiency and security of the donor processing records and the records area.
  • Monitors and prints results from internal and external laboratory databases, Sceris and other programs / systems, as required.
  • Proactively tracks lab results from internal and external laboratories and follows up with the lab as needed to ensure results are received in a timely manner. Communicates / escalates any issues which cannot be resolved through the normal channels
  • Enters lab test results into databases including QDDS, Access and Excel spreadsheets.
  • Prints, Scan and copies all the paperwork required for preparing the charts
  • Prepares charts with the appropriate paperwork and results for IFG, 1st Review and 2nd Review and Final Review.
  • Prepares (and may be required to present) performance metrics for the file room.
  • Responsible for identifying, tracking and retrieving and any mislaid charts.
  • Tracks processing records in and out of the file room using file coder or QAD.
  • Reviews and analyzes processing batch records to ensure the release criteria is acceptable in accordance with current finished good (FG) specifications, in-process finished goods (IFG) specifications, 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.
  • Completes appropriate documentation for the rejection of tissue and medical devices when required.
  • Reviews tissue and medical device processing and storage documentation
  • Interacts with all departments to organize, review, and analyze all data pertaining to the release of tissue or medical devices for compliance with current procedures, specifications and regulatory requirements.
  • Supports the Quality Analysts and all the Business Units with their queries on records.
  • Views and maintains the metrics for the global glass wall presentation / discussion.
  • Prepares, coordinates, arranges and reconciles shipments of documents required to send for offsite storage.
  • QA Contact for any required retrieval from the offsite storage facility.


  • High School Diploma/GED
  •  One year in a GMP or FDA regulated industry
  • Strong written and verbal communication skills. 
  • Must be proficient in data entry, Microsoft Outlook, Word, and Excel.
  • Must exhibit attention to detail, critical thinking, and problem-solving and effective communication skills.


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