We're looking for a Quality Specialist, working in the Biotechnology/Medical Devices industry in San Jose, California, United States.
Maintains and monitors document control system and equipment record status in compliance according to CAP/CLIA/CA/NY and other regulatory agencies.
Prepares for and participates in internal audits of the CLIA lab and supporting systems.
Maintains schedule of planned quarterly audits and/or management reviews.
Provides assistance to the CLIA lab for all CAPA and nonconformance investigation and resolution.
Oversees the CAPA and Nonconformance management systems.
We are offering Competitive Compensation and Benefits. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Bachelor’s degree in Chemistry, Biological Sciences or related field, or equivalent combination of education and work-related experience
1-2 years in the diagnostics or pharmaceutical industry dealing with quality (3-4 years experience preferred)
Experience working with CLIA, CAP, and NYS regulations / standards for operation of a clinical laboratory
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.