QA Document Control Specialist

Company Overview:

Forge Biologics is a hybrid gene therapy contract manufacturing and therapeutics development company.  Forge’s mission is to enable access to life changing gene therapies and help bring them from idea into reality.  Forge has a 200,000 ft² facility in Columbus, Ohio, “The Hearth,” to serve as their headquarters.  The Hearth is the home of a custom-designed cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing.  By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most. 

Position Overview:

We are currently seeking a QA Document Control Specialist to join the Forge Biologics team. In this newly created position, the QA Document Control Specialist will have oversight of all Document Control and Records Management functions for the company.

The individual chosen for this position will be responsible for all aspects of the document management system within the Electronic Quality Management System (eQMS), issuance of controlled Batch Production Records, and review of completed GxP documentation. The QA Document Control Specialist will play an integral part in the success of the Quality Control & Quality Management team at Forge. This position will be based in Columbus, Ohio.

Responsibilities:

• Coordinate and independently process internal documentation including but not limited to: SOP’s, Work Instructions, Forms, Batch Records, Methods, etc.
• Become a subject matter expert on the document management system with the eQMS (Veeva Vault) so you can provide guidance to users on document authoring and revision
• Evaluate and assess impact utilizing document change controls in the eQMS
• Issue controlled documentation including Batch Records to manufacturing
• Reconcile and review completed GxP documentation including process related forms and batch records
• Scan and process executed batch records and other GxP documentation into the eQMS.
• Assist with the creation and reporting of metrics and internal KPI’s related to the document management system
• Identify and implement document control process improvements to ensure compliance with internal and regulatory requirements
• Participate in the periodic maintenance and upgrades to the document management system including revising procedures and performing validation activities
• Provide support during regulatory inspections as well as internal audits

Qualifications:

• High School Diploma/G.E.D Required. Associates or Bachelor’s Degree preferred.
• 1-3 year(s) of experience in a GMP FDA regulated industry.
• 1-3 year(s) of experience in Quality Assurance or Document Control role in a GMP FDA regulated industry preferred.
• Intermediate level skill in Microsoft Word, Excel, Outlook and other office software programs.
• Experience with eQMS (Veeva Vault) or document management software preferred.
• Detail oriented and great organizational skills.
• Effective communication skills.