JobMesh

Quality Control Associate Bioanalytical Laboratory

Meso Scale Diagnostics, LLC · Gaithersburg, Maryland, US

POSITION SUMMARY: The Quality Control Associate provides support to the Bioanalytical Laboratory (BAL) staff for sample testing studies, including those perf...

Job description

POSITION SUMMARY: The Quality Control Associate provides support to the Bioanalytical Laboratory (BAL) staff for sample testing studies, including those performed under applicable elements of Good Laboratory Practices (GLP) and/or Good Clinical Laboratory Practices (GCLP), under direct supervision. This includes, but is not limited to, performing Quality Control review of study data and all laboratory and study-related documentation for accuracy and adherence to applicable plans, protocols, and policies. DUTIES AND RESPONSIBILITIES: - Performs Quality Control review of study data, reports, logs, equipment records, and other laboratory documentation to identify errors and deviations. - Communicates and works with bioanalytical principal investigators (BPIs), study coordinators, and lab personnel to resolve any identified issues and ensures all issues are resolved in a timely manner. - Keeps detailed records of findings and their resolution. - Escalates unresolved issues to managers, as necessary. - Performs all study-related activities according to the appropriate Standard Operating Procedures (SOPs), GLP/GCLP (if applicable), Good Documentation Practices (GDP), and statements of wo...