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Document Control SpecialistOrion GroupNew York, New York, United States

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Document Control Specialist

Orion Group
  • US
    New York, New York, United States
  • US
    New York, New York, United States

À propos

Document Control Specialist
6-Month Contract | $43–$47/HR (Depending on Benefits Selection)
**Onsite/Hybrid as required by client

Branchburg, NJ
Position Summary**
The Document Control Specialist will support the creation, maintenance, and lifecycle management of controlled documentation within the electronic Document Management System (eDMS). This role is critical to ensuring documentation accuracy, regulatory compliance, and timely availability of records for Manufacturing and Quality Operations. The specialist will review document change requests, coordinate routing and approval workflows, and maintain the integrity of the Document Control System in accordance with internal procedures and industry regulations.

This is an excellent opportunity for a detail-oriented professional with strong organizational skills and experience in a regulated pharmaceutical or medical device environment.

Responsibilities

  • Review, update, and process document change requests (DCRs) related to SOPs, policies, manufacturing documentation, master batch records, forms, and other controlled documents.
  • Coordinate the creation, revision, approval, and implementation of controlled documents within the eDMS (e.g., Veeva Vault).
  • Ensure all required approvals are secured prior to final document release; communicate effective dates to stakeholder departments.
  • Prepare and issue records to Manufacturing and Production teams, ensuring accuracy and readiness.
  • Maintain and administer the periodic review program for controlled documentation.
  • Organize, track, and archive controlled documents to ensure compliance with current regulatory and quality requirements.
  • Perform proofreading, formatting, and compliance checks to ensure documents meet quality standards.
  • Collaborate cross-functionally with QA, Manufacturing, Regulatory, and other departments to support document lifecycle needs.
  • Complete routine tasks and special projects with minimal supervision while meeting deadlines.

Qualifications
Education

  • Bachelor's degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or a related scientific/technical field preferred.

Experience

  • 3+ years' experience in quality assurance, quality systems, document control, or related roles.
  • Experience within a regulated pharmaceutical or medical device environment strongly preferred.
  • Proficiency in Microsoft Word and Excel; experience with eDMS platforms (Veeva Vault preferred).
  • Strong proofreading, written communication, and documentation accuracy skills.
  • Demonstrated analytical, decision-making, and problem-solving abilities.
  • Ability to work independently and collaboratively within a team.

Soft Skills

  • Excellent interpersonal skills and ability to work with cross-functional partners.
  • Strong time-management skills with ability to juggle multiple priorities.
  • Ability to identify issues, communicate effectively, and drive resolutions to completion.

Leadership & Professional Competencies
(Select up to three based on hiring manager preference; examples below)

  • Drive for Results
    – Consistently delivers high-quality, timely outcomes.
  • Decision Quality
    – Applies sound judgment in a regulated environment.
  • Collaborative Partnering
    – Builds strong relationships across teams to support compliance and operational goals.

Our role in supporting 
diversity
 and 
inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

  • New York, New York, United States

Compétences linguistiques

  • English
Avis aux utilisateurs

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