Document Control Specialist | Wayne, NJ

Detailed Information

  • Location: Totowa, NJ

  • Company: Sofie

Good Manufacturing Practices (CGMPs). The Document Control Specialist provides support to all company sites and other departments as needed to maintain production schedules and meet company goals. Maintaining all elements of the document lifecycle such as editing, reviewing, tracking, issuing, and filing of controlled documentation as per applicable Standard Operating Procedures is essential.

Essential Duties and Responsibilities Responsible for the revision, distribution, and maintenance of controlled documents including Standard Operating Procedures, specifications, protocols, and other miscellaneous documents Responsible for maintaining controlled document libraries Responsible for

opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions Prepare controlled documents through the change control process including editing, proofreading, tracking, copying, distributing, scanning, and filing Assign and track memos, protocols, and other quality documents Administrative tasks such as signature process, filing, Audit controlled document files to meet audit schedule Provide support for regulatory inspections and client audits Ensure all work is performed and documented in accordance with c GMP requirements and existing company policies and procedures Able to perform tasks with minimal error rate

Perform any other tasks/duties as assigned Qualifications and Requirements AS Degree in a related field with 2+ years of experience in Quality Assurance or Document Control function in an FDA regulated environment preferred Experience in a medical manufacturing environment is preferred Must be able to do work independently, recognizing what needs to be done and accomplishing it with minimal supervision Detail-oriented and committed to strictly following written procedures Advanced skills in Microsoft Word and Excel are required Excellent organizational, interpersonal and communication skills (written and oral) required Ability to take feedback constructively and function in a team-oriented work environment Ability to work overtime as needed.

PDN-9ad5bcdc-557a-44fe-9cdc-54e358d5774d

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