Document Control Specialist
Our client, a leader in the medical device and regulated life sciences industry, is seeking a dedicated Document Control Specialist to join their team. As a Document Control Specialist, you will be an integral part of the Quality Management System supporting documentation processes. The ideal candidate will demonstrate meticulous attention to detail, proactive problem-solving skills, and excellent communication abilities, which will align successfully within the organization.
Job Title : Document Control Specialist
Location : Wayne, NJ
Pay Range : $40-45 / hourly
Shift : 8AM-5PM EST
What's the Job?
- Facilitate the Document Change Request (DCR) process, including review, coordination, approval, and implementation of document updates.
- Ensure all DCRs include impact assessments, approvals, training linkage, and implementation plans prior to document release.
- Manage timely processing, release, obsolescence, archival, and periodic review of documents in compliance with internal procedures and regulatory standards.
- Proofread and review documents within the Quality Management System to verify accuracy, effective dates, and adherence to Good Documentation Practices (GDP).
- Support and guide document users on electronic Documentation Management System (eDMS), DCR processes, and troubleshooting system issues.
What's Needed?
Bachelor's Degree or equivalent in a related field or relevant work experience in document control or regulated industries.Minimum of 3 years of experience in document control within the medical device, pharmaceutical, or regulated life sciences industry.Hands-on experience with electronic Document Management Systems (eDMS) such as M-Files, MasterControl, Veeva, TrackWise DOC, or Documentum.Working knowledge of US FDA and ISO 13485 requirements is a MUST.Strong problem-solving, communication, organizational, and proofreading skills, with the ability to work independently and manage multiple priorities effectively.What's in it for me?
Opportunity to contribute to a vital industry supporting health and safety standards.Engage in a collaborative and inclusive work environment that values diversity and innovation.Gain experience with leading electronic Document Management Systems and regulatory compliance processes.Work remotely with flexible options to support work-life balance.Be part of a company recognized for its commitment to ethical practices and employee development.