Document Control Specialist

Orion Group; New Jersey; Hybrid; USD 59,236 - 64,747; Full time

Job summary

A leading recruitment agency is looking for a Document Control Specialist for a 6-month contract. The role involves supporting the lifecycle management of controlled documentation and ensuring compliance with regulatory standards. Candidates should have at least 3 years of experience in quality assurance or document control, especially within a regulated environment, along with a relevant Bachelor's degree. Strong skills in Microsoft Word and Excel are essential for this position. This position is located in Branchburg, NJ, with onsite/hybrid options.

Qualifications

• 3+ years’ experience in quality assurance or document control.
• Experience in regulated pharmaceutical or medical device environments.
• Proficient in document management and formatting.

Responsibilities

• Review and process document change requests.
• Coordinate controlled documents within the eDMS.
• Ensure approvals before final document release.
• Administer periodic reviews for controlled documentation.

Skills

Document control

Quality assurance

Analytical skills

Time management

Education

Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or a related scientific/technical field

Tools

Microsoft Word

Microsoft Excel

eDMS platforms (Veeva Vault)

Job description

Document Control Specialist

6-Month Contract | $43–$47/HR (Depending on Benefits Selection)

Onsite/Hybrid as required by client – Branchburg, NJ

Base Pay Range

$43.00/hr - $47.00/hr

Direct message the job poster from Orion Group

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.

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

• 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.

Diversity & Inclusion

We are committed to sourcing personnel that reflects the diversity and values of our client base and Orion Group. We welcome diverse perspectives based on nationality, gender, culture, education, background, race, ethnicity, sexual orientation, gender identity, disability, age, and more. Everyone is assured fair, respectful treatment irrespective of employment status.

Seniority Level

Not Applicable

Employment Type

Full-time

Job Function

Quality Assurance

Industries

Professional Services, Biotechnology Research, and Research Services