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Document Controller

Marlborough, MA
Enterprise Project Document Controller

Role Summary/Purpose:
As a key member of the PMO (Project Management Office), the Enterprise Project Document Controller shall provide proficient and effective support to the project teams to ensure all project documentation goals are met. Primarily, the job holder shall manage a portfolio of projects, Document Management Systems and related documentation processes in accordance with internal QMS procedures, specified good documentation practices and specific customer requirements. This position calls for an experienced document control individual to further develop the current document management systems & processes and formulate and implement future DC strategy (Veeva) while managing a wide range/high volume of time sensitive project related documents currently being prepared and circulated by the various parties involved in global projects.
Essential Responsibilities:
Responsible for all aspects of project documentation including but not limited to project operations and programs support including standardization, quality management, methods creation and maintenance, process improvement and tools for the project management and related functions.
•    DMS system design, project planning and implementation (preferably with Veeva application).
•    Control all aspects of project documentation on multiple simultaneous global projects, utilizing various control methods/systems.
•    Prepare, operate, maintain and update Document Control Procedures in line with the Company’s Document Management Systems.
•    Prepares and implements document controls processes to ensure procedures, correspondence, instructions and other project documentation are properly approved, issued, distributed and maintained.
•    Ensure proper document control support is given to each project within the global portfolio.
•    Liaise with customers on documentation transmittals.
•    Produce and maintain Document Progress Reports to Project Managers and other interested parties.
•    Work in strict co-operation with Project Managers to ensure project progress status integration.
•    Responsible for oversight, structure and maintenance of all document management systems, process & tools.
•    Review client specifications for the particular project and identify any requirements that give rise to deviations from the standard document management process.
•    Review status of the documentation, including overdue actions, non-conformities and customer communications and generate periodic reports as per agreed project routine.
•    Support the PM and Team in the generation and submission of the periodic Customer reports as required by the Contract.
•    Maintain Documentation Forecast dates and interface with the PMO Master Scheduler.
•    Arrange, attend and minute internal and internal & external project meetings as required.
•    Acting as the focal point for all Document Control matters relating to the customer. He or she shall ensure that all Project Document specialists are performing tasks according to this procedure and any relevant Customer Procedure.
•    Perform document control quality check before submission of documents to client.
•    Ensure Compliance with all DC Procedures, internal and external.
•    Coordinate all documents received from Customer and sites involved in the Project.
•    Chairing meetings with Project Leaders/Team to review status of the documentation on a weekly or other agreed periodic basis Qualifications / Requirements •    Applicable Document Control experience of 5+ within Project Engineering, Design, Commissioning & Qualification documentation, preferably related to the Life Sciences/Bio Medical industry. •    Need to be skilled in use of IT tools for document control and distribution, document scheduling etc.
•    Work on a high accuracy level, able to manage heavy work loads and understand work methods and routines as outlined in DCC procedures and tools.
•    Self-directed and highly-motivated with ability to prioritize tasks and communicate at all levels.
•    Excellent written and verbal interpersonal skills and the ability to work well in a team.
•    Able to work in a fast-paced and deadline-driven environment.
•    Detail-oriented, dependable and trustworthy.
•    Excellent MS Suite software knowledge.
•    Process/Operational Excellence, Lean and Continuous Improvement practical knowledge.
•    Good working knowledge of Veeva, Adobe Acrobat & BOX.
•    Familiar with e-Document management systems (Sharepoint, Prologic, EDMS, Veeva, etc.)

Desired Characteristics:
•    Document Control: Has a good understanding of and a thorough approach to setting up and maintaining document control systems and processes.
•    Contract Awareness: Can establish duties and responsibilities required of their role through reviewing the Contract. Sets up and maintains systems to deliver against these.
•    Customer Service Orientation - Satisfying customers, both internal and external.
•    Adaptability - Willingness to deal with unexpected challenges or circumstances.
•    Problem Solving - Defining problems and bring about viable solution.
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