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Document Control Manager (remote)

Company: Cambrex
Location: Portland
Posted on: June 18, 2022

Job Description:

Company InformationCambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and European sites, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.At Cambrex, our people set us apart. We're committed to attracting, nurturing, and retaining a passionate and talented team of valued experts in our fast-paced and growing company. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings!Known for our scientific and manufacturing excellence, as well as our strong customer focus, we offer a range of career opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world.OverviewThe 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 Help Desk support to all MasterControl site(s) users at Cambrex in problem resolution and system operation.Responsibilities

  • Reports to Manager Quality Management Systems
  • Ability to work in a fast-paced environment, managing multiple tasks or projects.
  • Works with Quality Management to ensure that documents are properly processed in MasterControl.
  • Provide support and assistance for internal and external audits.
  • 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 Help Desk 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. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Keywords: Cambrex, Portland , Document Control Manager (remote), Executive , Portland, Maine

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