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Document Control Manager

Location

Durham, NC, USA

Department

Quality Assurance

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At Cambrex, it’s our people that set us apart. We work locally and have an impact globally. We’re committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, STD, LTD, generous vacation in your first year, sick time, and retirement savings!
Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.

Overview

Overview

The Document Control Manager creates effective processes to ensure GxP Document Control is conducted in a timely manner and is accurately recorded. This role is responsible for effective processing and maintaining the Electronic Quality System, MasterControl, to support GxP Document Control processes.

As a Document Control Manager, you will manage electronic document processes (daily maintenance, tracking, workflow, document formatting/editing, closure) to ensure adherence to company and regulatory requirements and best practices as well as manage the MasterControl platform.

You will coordinate with appropriate departments and/or cross-functional teams to ensure all applicable documents are reviewed and revised within the specified timeframes; receive proposed draft documents from originators; and perform initial review on draft documents whether hard copy or within the EDMS.

Participate directly in providing HelpDesk support to all MasterControl site(s) users at Cambrex in problem resolution and system operation.

Responsibilities

Responsibilities

  • Reports to the Manager, Quality Management Systems
  • Works with Quality Management to ensure that documents are properly processed in MasterControl.
  • Document Control Room gatekeeper managing hard copy record structure, labelling, archiving documentation, and preparation of shipping and receiving records to off-site storage facilities or retrieving (when applicable).
  • Train new hires and assist with retraining as required, one-on-one; group sessions; remote or classroom environment.  Evaluate training effectiveness and remedy deficiencies.
  • Directly engaged in providing routine MasterControl HelpDesk support to all MasterControl Cambrex site(s) users in resolving basic to advanced problems, issues and troubleshooting.

Qualifications

  • 5+ years of relevant pharmaceutical experience required.
  • Previous experience with regulated document control in a multi-site environment and with direct experience in electronic document management systems.
  • Relevant experience with a QMS (MasterControl a plus) document software is required.
  • Experience as a sub administrator / or system administrator in the MasterControl platform required.
  • Experience using Microsoft Office applications (Word, Excel, PowerPoint), email, and calendar programs.
  • Effective communication skills and ability to train co-workers with varied educational backgrounds and experiences.
  • Strong attention to detail, teamwork, organizational and workload planning skills.