Quality Assurance Specialist Job in Cambridge 02141, Massachusetts US
We are a 6 year old product based, profitable biotechnology start up with our home base in the Pacific Northwest. Our expansion goals bring us to Cambridge, MA where we are augmenting our services with a technology development laboratory focused on novel molecular technologies and products. Our first product platform in New England will be Nex Gen Sequencing. We have hired our scientific and bioinformatics team and now we need to establish CLIA/CAP/NY State laboratory certification. To this end we are committed to hiring a Quality Assurance Specialist to lead us in this effort.
Primary responsibilities:
Ensure compliance with applicable federal, state and local regulations supporting CAP, CLIA and NY State laboratory certification;
Interpret and implement quality assurance standards in concert with home base activities;
Manage required documentation and ensure site is inspection ready at all times;
Participate in internal, external and compliance audits in accordance with regulatory standards;
Assist in formulating and maintaining QC objectives to meet laboratory and corporate policies and goals.
Experience:
We require thorough knowledge and specific experience of what is necessary to maintain CLIA, CAP and NY State regulatory standards, sound communication skills, both written and verbal and experience in technical writing for documentation of requisite SOPs. These outline key responsibilities with other QA/QC requirements to be discussed in the course of the interview process.
Academically, a degree in a life science and minimally 2 years of QA responsibility in a regulated environment is required.
This assignment will have dual reporting relationships, functionally to the QA Director in Portland, OR and locally to site management in Cambridge, MA.