Document Control/Project Admin (Contract Position)

Document Control

Key Responsibilities

• Check the project mailbox daily.

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

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

• Assist the internalteam in updating theinternal Document Register/MDL.

• Solely responsible for updating the External MDL.

• Ensure content on both MDLs accurately reflectsdocuments 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 NumberingProcedure.

• Project template and cover page applied.

• Issued documents arein .pdf format or a locked Excel sheet.

• Consistent spacingand 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 AdobeDocuSign.

• 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.

• Trackaction items generated in team meetings using theAction Log (found on left sidebar of Internal SharePoint).

• The APMwill be responsible for taking notes and highlighting action items inyellow.TheDC/Admin’s responsible for entering these action items into the Action Log, assigningresponsibility, andentering a due date.

• TheDC/Adminwill go over past-due action items at the weekly team meetings.

• Action items can be generated inJFs, 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(foundon 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.