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Document Control Lead (cGMP - Pharmaceutical) JD817627

JD817627

DPS is looking for a Document Control Lead to assist with a BioPharma client in the Boston, MA area. This individual would be responsible for the setting up and management of a Document Control System to support a large capital project.

Category:
Document Controller
Location:
Massachusetts
Years of Experience Req.:
4+
Date Posted:
31/05/2019
Days Remaining:
29
Employment Type:
Full-time
Education Level Req.:
Bachelors Preferred

Document Control Lead (cGMP)                  JD817627

Boston, MA area

 

Summary:

 

DPS Engineering is looking for a Document Control Lead to assist with a BioPharma client in the Boston, MA area. This individual would be responsible for the setting up and management of a Document Control System to support a large capital project.

 

Responsibilities:

  • Management and organiz478042.756541ation of a document system for receipt and distribution, traceability, retrieval, and archiving; all project-related documents consistent with contract requirements and workflow procedures.
  • Responsible for the development, implementation, and maintenance of the Engineering, Construction and commissioning  document management system together with all associated documents ensuring compliance with regulatory, corporate and site requirements.
  • Primary responsibilities to focus on managing the Document Control process, managing records control, and record storage.
  • Manage receipt of all design, construction documents from vendors, subcontractors and other 3rd parties as required.
  • Ensure submittals are routed to appropriate personnel for approval.
  • Serve as Document Manager across all project disciplines relevant to project and will be responsible for quality control process procedures including routing and tracking of all project documents such as contracts, submittals, specifications, issued for construction documents (IFC), As-Built, Evidence Binder and Turnover packages. These processes will require interaction with project sponsors, design engineers, vendors, suppliers, project team, and subcontractors.
  • Responsible for complete life-cycle of procedural document creation, routing, and database uploading.
  • Ensure that all required signatures are included on project documentation.
  • Maintain the project’s library of technical documents (blue prints, As-builds, Photographic archiving, etc.)
  • Maintain archived engineering, architectural, and construction documents, including design drawings, vendor submittals, shop drawings, design review records, special studies, and other documents as required.

 

Qualifications:

  • Bachelor’s degree is desired but not required and replaceable by experience.
  • A minimum of 4 years of experience as a document control specialist is required.
  • Requires excellent organiz478042.756541ational, interpersonal, and communications skills.
  • Must exhibit professional behavior and appearance and be aware of the importance of teamwork within the assigned department.
  • Ability to read, write, reason, analyz478042.756541e, evaluate, problem solve, perform mathematical calculations and allocate resources as appropriate.
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