We are seeking a QC Data Reviewer to join our team! The QC Data Reviewer will provide data review and reporting for in-process, release, stability, EM, CoA, summary reports, method qualification and method transfer testing activities. This position is a non-lab based position and in this role, this individual will review data for accuracy and compliance to applicable Standard Operating Procedures (SOPs), protocols, and regulatory guidelines.
About this Role:
- Evaluates data to ensure compliance with methods, client criteria, Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP)
- Perform detailed data review for test results on assays such as ELISA, DNA/RNA extraction and gel electrophoresis, PCR, HPLC, Capillary Electrophoresis, Bioburden, Endotoxin, etc.
- Reviews sample results tables and analytical reports for completeness and accurate representation of the data and report findings
- Prepare QC statements noting deficiences with the analytical data set or notebooks
- Communicate with laboratory staff to proactively address the quality of laboratory documentation
- Utilize the electronic files and reporting systems for review of complied data and manual entry
- Respond to QA inspection report findings related to QC review of data
- Participate in investigations for OOS/OOT results and Unplanned Events (deviations)
- Work cross-functionally with QA, Assay Validation, and Manufacturing to drive closure of quality systems items
- Consults with supervisor regarding priority assignments