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Specialist II, Document and Records Management - R-100997 - Marlborough, MA

Company: National Resilience
Location: New Bedford
Posted on: November 22, 2021

Job Description:

Position Summary & RoleThis role is accountable for supporting and maintaining a compliant, well-organized, and effective GMP document management program at a highly digital manufacturing plant. This is a great opportunity to create the document architecture and processes for a new facility, working collaboratively across all site functions relying heavily on digital technologies. The responsibilities for this role will cover all aspects of a GMP document lifecycle, from creation through review, approval, execution, retrieval, archival and destruction. The Document and Records Management Specialist is a key quality systems support function across the site and reports to the Head of Quality Systems & Compliance. The position will be located in Marlborough, MA.Job Responsibilities

  • Ensures quality activities are carried out according to regulatory and quality requirements.
  • Support the development, implementation and maintenance of the site documentation. management system and ensures alignment with network standards.
  • Support the day-to-day document control activities for site operations, some activities may include but not limited to data entry, metric reporting, filing and archiving.
  • Manage the documentation lifecycle which includes documentation formatting without changing content to ensure consistency across documents. Coordinate workflows with task owners to ensure that documents are properly reviewed, issued, approved, periodically reviewed and obsoleted within identified timeframes. Follow up with document owners to ensure that records are completed and documented within established timeframes.
  • Acts as a technical system expert and supports, manages and monitors the global electronic Document Management System (eDMS), electronic Quality Management System (eQMS) and the electronic Learning Management System (eLMS).
  • Maintains and facilitates trainings related to the users of the eDMS, eQMS and eLMS in coordination with QA Training.
  • Support the development of a site-wide visible business process and expert community to ensure high-quality documents
  • Participate in network communities of practice related to DMS and Veeva.
  • Support efforts for site Audit readiness and participates as an audit team member.Preferred Experience, Education & Qualifications
    • Bachelor's degree or higher in Data/Information Management or related field
    • Minimum of 3 years of GMP document control or GMP data management experience
    • Hands-on experience with creation of GMP documents (e.g. procedures, forms, BRs, etc.)
    • Comprehensive knowledge of GMP regulations for document and records management
    • Prior experience with managing electronic document management system (Veeva)Other Ideal Personal Characteristics:
      • Reputation for superior customer service
      • Strong cross-functional and matrix team leadership
      • Driven to reduce complexity and create simple and organized data systems
      • Proficiency in creating high quality procedures that are easy to read and understood
      • Desire and interest to leverage new technology and innovative information management tools
      • Excellent interpersonal, verbal and written communication skills
      • Experience in application of lean methodologies and operational excellence to continuously improve

Keywords: National Resilience, New Bedford , Specialist II, Document and Records Management - R-100997 - Marlborough, MA, Executive , New Bedford, Massachusetts

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