Associate, QA Document Control - QA9


Full-time

Menlo Park, California, United States

Quality Assurance

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.

PRIMARY RESPONSIBILITIES:

  • Assist in the management of document and record workflows within the EDMS
  • As required, scan, index and upload documents and records in to EDMS
  • Assist in training and support of EDMS end users
  • Assist in the development of training modules and qualification curriculums in the LMS
  • Assist in the assignment of training curriculums
  • Assist in the maintenance of electronic and/or hard-copy archives for applicable GxP records

Requirements

SKILLS AND ABILITIES:

  • A minimum of three years’ experience working within a GxP regulated environment.
  • Prior experience working within a EDMS required
  • Experience using a Learning Management System (LMS) required
  • Strong communication skills (written and verbal).
  • Customer service skills.
  • Practical understanding of documents and records used within the Pharmaceutical industry.
  • Self-motivated, flexible & creative, able to prioritize, multi-task and work in a fast-paced & demanding environment.

Profile:

  • Bachelor’s Degree in a life sciences related field preferred
  • A minimum of 3 years of Quality Assurance, Document Control, Records Management and Archiving experience in a biotech or pharmaceutical company preferred.
  • Experience with EDMS workflows required.
  • Experience using a Learning Management System (LMS) desired.
  • Proficient in pertinent software & tools.
  • Must be knowledgeable of industry documentation types and Good Documentation Practices (GDP).