San Jose based Visby Medical is an ambitious, well-funded, and fast-paced early stage biotech startup. Driven by a belief that disease diagnosis should be quick, accurate, and accessible to all, Visby is developing a novel diagnostic device platform that aims to redefine the way an infectious disease is tested and treated.
We are developing a tenacious team with deep industry expertise of researchers, biologists, designers, and engineers that is back-stopped by world class operations and administrative resources. If you enjoy tackling challenging problems, are passionate about your work product, and want to join a collaborative ownership team that is aiming to leave a lasting positive legacy in the healthcare industry, please consider the following QC Method Development Scientist opportunity.
The QC Method Development Scientist will be responsible for supporting the development and validation of QC assays in compliance with ISO 13485 and FDA QSR. The QC Method Development Scientist will demonstrate a high level of individual responsibility and accountability.
Essential Duties (Identify which are QMS responsibilities)
- Define, develop, and refine QC methods to characterize reagents and transfer methods to the QC team.
- Create, update, review and develop QC laboratory standard operating procedures and supporting work instructions in compliance with ISO 13485 and FDA QSR.
- Write and perform QC method qualification, verification/validation protocols.
- Support environmental monitoring of utilities and facilities.
- Complete investigations for Out of Specification (OOS), CAPA, deviations, and perform trending analysis.
- Maintain a safe, organized, and clean work environment.
- Other duties as assigned.
Education and/or Experience
- Minimum 3 years of assay development and validation experience in a regulated environment.
- BS in science required; Microbiology, Chemistry, or related discipline a plus; MS or PhD preferred.
- Excellent written and interpersonal communication skills.
- Comfortable performing repetitive tasks and/or motions.
- Must be able to lift a minimum of 10 lbs.