We are looking for a Quality Systems Specialist, working in the Pharmaceuticals & Medical Products industry in Fremont, California, United States.
Provide QRM support / expertise to Fremont site via facilitation of risk assessments, authoring of quality risk reports, and delivery of QRM training; support division with revisions to global procedures and sharing of best practices
Facilitate / lead risk assessments and author summary report
Use ICH Q9 / ISO 14971 principles and risk management methods / tools to facilitate risk assessments (e.g. FMEA, Fault Tree Analysis, etc.)
Maintain and make improvements to Quality Risk Management share room and associated QRM resources (e.g. Risk Registry, Periodic Review tracker, etc.)
The pay we are offering is 45 per hour. 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
BS degree from an accredited institution, in Microbiology, Biology, Chemistry (Or closely related degree with these core courses as the foundation)
Requires 8 years of pharmaceutical Quality Assurance/Systems experience
Practical knowledge of ICH Q9 and ISO 14971
Experience facilitating and leading risk assessments using risk management methods and tools
Experience leading projects with history of achieving results and outstanding outcomes; must possess strong organizational skills and be able to self-motivate and work independently
Solid knowledge of relevant regulations and guidance required in order to act as a resource for colleagues
Must possess excellent verbal and written communication skills; strong interpersonal skills absolutely required
Familiarity with Quality Management Systems and related regulatory guidelines
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.