Menlo Park, California, United States
Location: Menlo Park, California
Reporting to: Senior Manager, R&D Quality
Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases. Created two years ago, it is in an exciting start-up phase where a Quality Assurance professional can have a real impact on the work and foundations that are being created. This role will report to the Senior Manager, Document Control, located in Menlo Park, CA (US) and will be responsible for processing Quality Assurance and other essential documents via the use of the company’s Electronic Document Management System (EDMS), MasterControl.
This position reports to the Senior Manager, R&D Quality, who is responsible for the management and oversight of the R&D Quality functions such as Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Good Laboratory Practices (GLP).
The Document Control Associate is expected to have a working knowledge of FDA and EU regulations concerning Good x Practices (GxP) in order to ensure compliance to quality standards for documentation change control and records management. The ideal candidate will have experience in using Master Control.
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