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
• Maintain continuing knowledge of current CLIA, CAP, and relevant GxP regulations and requirements

Qualifications

Basic Qualifications: Possession of a Bachelor’s degree from an accredited college/university in a science field (preferably related to biomedical research) according to the Council for Higher Education Accreditation (CHEA) or four (4) years of relevant experience in lieu of a degree. Foreign degrees must be evaluated for U.S. equivalency. In addition to the education requirement, a minimum of two (2) years of progressively responsible experience; demonstrated track record of QA responsibilities; knowledge of molecular characterization laboratory operations; familiarity with Clinical Laboratory Improvement Act (CLIA) regulations and/or accrediting body standards, as well as FDA Good Laboratory/Clinical regulations; working knowledge of Microsoft Office applications (Word, Excel, PowerPoint) and any lab‑specific applications used in patient testing activities; excellent writing and editing skills with clear and effective presentation skills; ability to work within a highly matrixed team environment; ability to obtain and maintain a security clearance.

Preferred Qualifications: Performance of QA‑related tasks (manage deviations, training); prior use of MasterControl; familiarity with FDA submissions such as IND, IDE, etc.

Benefits

• Competitive compensation
• Health and Wellness programs
• Income Protection
• Paid Leave
• Retirement

Pay

The posted pay range for this position is $71,500.00 – $125,100.00 USD (full‑time equivalent). Actual compensation will be based on responsibilities, education, experience, knowledge, skills, internal equity, and market data.