Documentation Specialist

Location: Branchburg, NJ (Onsite)
Pay: $49–$53/hr
Schedule: Monday–Friday, 40 hours/week

JOB SUMMARY

The Documentation Specialist is responsible for reviewing, updating, and managing controlled documents within the electronic Document Management System (eDMS). This role supports document creation, revision, routing, approval, and implementation in compliance with current regulatory and quality requirements. Additional responsibilities include control and distribution of documents, preparation of records for production, and maintenance of the overall Document Control System.

KEY RESPONSIBILITIES

• Implement, control, and coordinate changes to documentation in the eDMS.

• Facilitate updates and routing of controlled documents including Governance documents, SOPs, policies, Master Forms, and Master Batch Records.

• Manage the full change process for manufacturing documentation, ensuring compliance with internal procedures and regulatory expectations.

• Review, edit, and process changes to controlled documentation (procedures, manufacturing records, forms, specifications, etc.).

• Verify that proper approvals are obtained prior to final document release.

• Coordinate effective dates with relevant departments and ensure timely document implementation.

• Prepare and issue production records as needed.

• Maintain the periodic document review system, ensuring documents remain current and accurate.

Complete assigned projects and routine tasks with minimal supervision.

EDUCATION & EXPERIENCE
 

• Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific discipline preferred.

• 3+ years of experience in Quality Assurance, Quality Oversight, or related field.

• Experience in a regulated pharmaceutical, medical device, or related industry strongly preferred.

• Hands-on experience with document management systems; Veeva Vault experience preferred.

• Proficient in Microsoft Word and Excel.

• Strong proofreading, writing, and verbal communication skills.

• Excellent analytical, decision-making, and problem-solving abilities.

• Proven ability to work both independently and collaboratively within team environments.

• Strong interpersonal skills and ability to follow through on action plans to resolve issues.
  
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