QA Specialist II - MoCha
About the role
The QA Specialist II supports the Molecular Characterization Laboratory (MoCha), part of Leidos Biomedical Research’s Clinical Research Directorate (CRD) at the Frederick National Laboratory for Cancer Research. The laboratory has worked closely with the National Cancer Institute in support of Division of Cancer Treatment and Diagnosis (DCTD)-sponsored clinical trials and pre-clinical studies. We are dedicated to implementing cutting-edge genomic technologies to identify new predictive biomarkers and to make translational discoveries that will improve the lives of patients with cancer. The QA Specialist II assists with the oversight of regulated activities supporting clinical assay development and application in clinical trials, and release of test results. Will report directly to the Quality Assurance Manager II.
Responsibilities
- Perform record review for all patient-testing related records
- Generate and review documents (SOPs, forms, etc.) relevant to patient-testing activities and research activities intended for future use with patients or FDA submission
- Periodically observe laboratory activities to ensure that performance and quality conform to corporate and regulatory standards
- Implement, maintain and offer suggestions to improve upon existing quality management systems and activities supporting the clinical assay laboratory and designated clinical trial platforms as assigned
- Participate in interdepartmental quality initiatives and processes
- Evaluate and report on quality issues related to assay systems and processes
- Guide investigations and resolve quality issues with appropriate corrective and preventive actions
- Continuing knowledge