We are looking for a Electronic Systems Regulatory Compliance Specialist, working in the Biotechnology/Medical Devices industry in Foster City, California, United States.
Assist members of Electronic System Compliance in providing quality and compliance oversight for the computer system validation and the electronic records / electronic signatures compliance programs.
Conduct electronic record and electronic signature assessments and assist the business areas and IT in developing corrective action plans .
Work to ensure that up-to-date computer system inventories and assessments of regulated systems are maintained.
Assist with CRO/service provider audits, audits of software vendors and in-house audits, any of which may require travel.
The pay range we are offering is 60 to 77 per hour. This position may present an opportunity to go permanent.
Our client is a people driven staffing company. Growing fast - 33% annually!
How? Building trusting relationships with top candidates. Like you! You’ll get one-on-one time focused on your skills, needs, and discovering opportunities in which you’ll thrive. The goal is to place you in the right position for you and your goals.
Where? Top IT and telecommunications companies. You’ll make a difference and grow in Technology, Government Services, Professional Services, or Engineering.
Helping you achieve your goals! It’s the right way and the only way to succeed in staffing.
Experience Required for Your Success
BS degree and 5 to 7 years experience or MS and 4 years experience.
Previous experience in the biotechnology / pharmaceutical or related industry implementing and validating computer systems that manage regulated information is required.
Experience in performing 21 CFR Part 11 and Annex 11 assessments (gap analyses) and developing corrective action plans is required.
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.