#WomensHealth tech company developing DotEndo, a breakthrough blood test that aids in the diagnosis of active #endometriosis
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.
- 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
- 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