Records Management Coordinator

2 weeks ago


Allendale, New Jersey, United States Minaris Regenerative Medicine Full time
Job Overview

Position: Document Control Specialist

Company: Minaris Regenerative Medicine

At Minaris Regenerative Medicine, we are dedicated to pioneering advancements in cell and gene therapy. Our mission is to revolutionize the future of medicine through innovative therapies that transform lives.

The Document Control Specialist (DCS) plays a crucial role in overseeing the electronic Document Management System (eDMS). This includes the creation, regulation, and compliance of electronically generated documents under the guidance of the Document Control Manager. The DCS is tasked with managing all Records Management activities, including the storage, retention, and archival of original documents linked to Clinical Development, Technology Transfer, and Clinical/Commercial Manufacturing.

The DCS will also facilitate client and regulatory inspections by ensuring the availability of necessary documentation in response to audit requests. This role involves leading or co-leading cross-functional teams to synchronize and monitor Document Control and Records Management activities. Additionally, the DCS will engage in various project teams that align with the strategic vision of the department.

Key Responsibilities:

  1. Receive and document incoming records for Minaris locations.
  2. Prepare records for repository storage and file them appropriately.
  3. Manage record requests and ensure timely responses.
  4. Oversee the management of records retention programs.
  5. Train personnel on document authoring and review processes within the DMS.
  6. Perform administrative duties within the DMS, including creating and revising document templates.
  7. Ensure compliance with GDP standards and template adherence.

Qualifications:

  • Bachelor's degree in a relevant field.
  • A minimum of 5 years of experience in Records Management, preferably with GxP documents.
  • Experience in Clinical, Research, or Pharmaceutical settings is advantageous.
  • Proficiency in e-DMS and e-QMS systems.
  • Strong technical writing skills in a scientific context.

Competencies:

  • Excellent time management and organizational skills.
  • Ability to thrive in a fast-paced environment with multiple priorities.
  • Strong written and verbal communication abilities.
  • Effective problem-solving and decision-making skills.
  • Capability to collaborate effectively in a cross-functional team.

Working Environment:

This position operates within a professional office environment, with exposure to standard office equipment. The role may involve moderate noise levels typical of a manufacturing facility.

Physical Requirements:

The role is primarily sedentary, requiring occasional lifting of light objects and the ability to use standard office machinery. Close visual acuity is necessary for document preparation and review.

Disclaimer:

This job description is intended to provide a general overview of the position and is not exhaustive of all duties and responsibilities. Responsibilities may change as needed.



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