Quality Specialist I

DotLab is a personalized medicine company focused on women’s health and is starting with the development of a cutting-edge molecular diagnostic test for endometriosis. Ten percent of women of child-bearing age suffer from this debilitating disease, which takes an average of a decade to diagnose. We’re looking to change that.

We are hiring a Quality Specialist I to support DotLab’s Quality Management System in the clinical laboratory.

RESPONSIBILITIES

• Manage and maintain DotLab’s Document Control System and other Quality Management systems as needed
• Maintain training plans and ensure all employees have met their training and competency assessment requirements
• Perform final disposition of incoming materials and reagents including CoA/CoC acceptance review and updating disposition in the materials log
• Review documents including batch records, preventive maintenance logs, etc..
• Own the equipment master log and ensure calibration/verification activities are performed in a timely manner
• Participate in the nonconformance event process
• Support the onboarding process of new employees and maintain employee personnel files
• Assist with both internal and external audits/assessments
• Work closely with all laboratory personnel to identify continuous improvement opportunities
• Support IT related activities where needed (set up computer stations, track IT inventory)
• Serve as the Laboratory Safety Officer
• Report to the Quality Manager

REQUIREMENTS

• 1-2 years of Quality Assurance experience in the clinical laboratory or manufacturing setting
• BS in biological sciences preferred
• High level proficiency with Microsoft Office
• General knowledge of clinical laboratory regulatory bodies (CLIA, CAP, etc.) preferred
• Knowledge of NYS and other state requirements preferred
• Preference for candidates located in the Branford, CT area