Website hellodotlab DotLab
The future of women's healthcare, bringing you the first-ever test for #endometriosis
DotLab, a personalized medicine company focused on women’s health, is looking for an outstanding Quality Assurance Specialist to support the development of our cutting-edge molecular diagnostic test for endometriosis. Ten percent of women of child-bearing age suffer from this debilitating disease, which can take up to 8 years to diagnose… we’re looking to change that.
What you’ll be doing:
- Using your experience as a Quality Assurance (QA) professional in the implementation, continual improvement, and maintenance of DotLab’s Quality Management System (QMS).
- Representing QA on cross-functional teams (Operations, R&D, Materials, Clinical, & Marketing) to complete projects and ensure compliance with FDA, CLIA, ISO and other applicable regulations.
- Developing and implementing quality standards, protocols, strategic quality plans, master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet CLIA, CAP, NYS and FDA requirements.
- Implementing and maintaining a robust document control system, including the training of employees on the use of the system.
- Ensuring proper evaluation, timeliness and completeness of investigations, root cause analyses as well as corrective and preventive actions (CAPA).
- Establishing a nonconforming event management system including tracking timely resolution of events through corrective/preventive action.
- Participating in internal audits, supplier audits, and the assessment process by external parties (CLIA, CAP, NYS, FDA).
- Being responsible for the establishment and maintenance of hardcopy archives and files; QA review of records including material inspection records, batch history records, log books, and equipment files; QA inspection and release of materials for use in commercial and development operations; and project based assignments to improve the current QMS.
- Functioning as a problem solver, analyzing problems and helping to implement root cause solutions.
- Working in a fun and fast-paced, early stage start-up that is leading the change in the way that endometriosis is diagnosed.
What we’re looking for:
- Bachelor’s or Master’s degree in molecular biology, biochemistry, genetics, or a related field
- 5+ years of QA/QC-related experience in the diagnostic/device/pharmaceutical field.
- Thorough knowledge of Quality Management System regulations/requirements (i.e. CLIA, CAP, NYS, FDA, ISO, GMP)
- Ability to work in a start-up environment where processes are not always well defined and be comfortable working in a fast-paced environment
- Strong attention to detail and ability to see projects through to completion.
- Effective problem solving and analytical skills
- Excellent interpersonal, written, and verbal skills
- Experience with document control processes; electronic document management systems preferred
- Effective organization and planning skills
- Professional certification is a bonus (i.e. CQA-Certified Quality Auditor, CQE-Certified Quality Engineer, SQE-Software Quality Engineer, CQM-Certified Quality Manager, etc.)
- Basic to intermediate proficiency in Microsoft Office and statistical programs (i.e. MiniTab, SAS) is a plus
- A working style of hands-on involvement with all phases of her/his projects
- Ability to be flexible, creative, and have fun as DotLab grows!