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.