The Children's GMP, LLC has an open Document Control Specialist position available. The Document Control Specialist manages the documentation process with the objective that all documents are appropriately designed, consistently formatted, and successfully archived to facilitate and promote business objectives. This position is responsible for the issuance and management of all controlled documents approved by Quality Assurance. This position ensures that all executed records are archived electronically in designated repositories and the hard copy originals are filed per procedure. This position is responsible for ensuring that all new and revised documents are produced using the appropriate templates and contain all elements specified in the GMP regulations. This position works directly with authors and assists with writing and editing controlled documents.
Bachelor's Degree required
Minimum 2 years of experience in Quality Assurance, preferably in an FDA regulated environment
Previous experience in a pharmaceutical or biopharmaceutical company with a role in Quality Assurance including document management, change control, audits, batch record and label issuance required.
Prior experience maintaining a structured document and electronic record management system is preferred.
Scientific background including education or prior exposure to bioprocessing and manufacturing of cellular therapy products is preferred, but not required.
Previous experience with copy editing is preferred.
Position will utilitze Microsoft Word daily for routine and complex document editing and mastery of this application is essential.
St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.