Document Control 

Key Responsibilities 

• Check the project mailbox daily.  

• Send official notifications of document issuance to affected individuals or groups through the project mailbox. Notifications are to be issued within 2 business days of receiving communication of a new revision or document upload.  

• Owner of the Master Document List (MDL) on both internal and external SharePoint websites.  

• Assist the internal team in updating the internal Document Register/MDL. 

• Solely responsible for updating the External MDL. 

• Ensure content on both MDLs accurately reflects documents stored on internal and external SharePoint websites.  

• Ensure folder structures are created and populated per the Document Control Procedures. 

• Check the project governing documents meet formatting standards. 

• Files named per Document Numbering Procedure. 

• Project template and cover page applied. 

• Issued documents are in .pdf format or a locked Excel sheet. 

• Consistent spacing and font throughout document. 

• Table of contents when deemed necessary.  

• Manage redline workflows for drawings and specifications.  

• When applicable, route documents for review and approval through Adobe DocuSign. 

• Co-owner of Document Control Procedure, along with Assistant Project Manager (APM).  

• Propose and implement changes and improvements.  

• Co-owner of Communications Matrix, along with APM. 

• Remove and add people as necessary.  

• Propose and implement changes and improvements. 

• Owner of document templates (Word, PowerPoint, Excel). 

• Update as necessary. 

• Propose and implement changes and improvements. 

• Should the project transition to a different document control software after selecting a General Contractor, the DC/Admin will support this transition. 

Administration 

Key Responsibilities 

• Co-owner of Contact List, along with APM. 

• Remove and add people as necessary. 

• Track action items generated in team meetings using the Action Log (found on left sidebar of Internal SharePoint). 

• The APM will be responsible for taking notes and highlighting action items in yellow. The DC/Admin’s responsible for entering these action items into the Action Log, assigning responsibility, and entering a due date. 

• The DC/Admin will go over past-due action items at the weekly team meetings. 

• Action items can be generated in JFs, team meetings, stakeholder meetings, contractor meetings, etc. All meeting minutes are captured in the Project Notebook (OneNote). 

• Ensure changes made to the fit, form, or function of the project are tracked in the Change & Decision Log (found on left sidebar of Internal SharePoint). 

REQUIREMENTS

• Bachelor's degree from an accredited university, or an equivalent combination of education and experience.

• Minimum of five (5) years of experience in document control within a regulated environment.

• Five (5) to ten (10) years of progressively responsible administrative experience.

• Demonstrated knowledge of current Good Manufacturing Practices (cGMP), including experience interpreting and applying cGMP requirements related to finished dosage forms.

• Strong organizational and time-management skills, with the ability to effectively manage multiple priorities and deadlines.

• Proven analytical and problem-solving skills with a high degree of attention to detail.

• Excellent written and verbal communication skills.

• Strong interpersonal skills with the ability to build effective working relationships across all levels of the organization.

• Advanced proficiency in Microsoft Office applications, including Word, Excel, Access and SharePoint.

• Self-motivated and proactive, with the ability to work independently and take initiative in a fast-paced environment.