Quality Documentation & Change Control Specialist

Quality Documentation & Change Control Specialist
(Documentation Specialist III)
Location: 100% Onsite
Schedule: Full-Time, Onsite- Branchburg, NJ
Contract through end of 2026 with potential extensions
Up to $28/hr based on benefit selections
 
About the Role
Orion Group is seeking an experienced Quality Documentation & Change Control Specialist to support documentation and change control activities for our highly regulated pharmaceutical client in Branchburg, NJ!

This role will manage complex and business-critical change requests, controlled documentation, and associated workflows using TrackWise and an Electronic Document Management System (EDMS).

The ideal candidate brings a strong background in Quality, Change Control, and Document Control within the medical device or another highly regulated industry and is comfortable independently evaluating change requests, identifying quality concerns, and guiding stakeholders through compliant solutions.
This individual will also serve as a Subject Matter Expert (SME) for Quality Documentation and Change Control, support regulatory audits, participate in cross-functional initiatives, and provide guidance to other team members.

Key Responsibilities

• Review, evaluate, and process complex, high-priority and business-critical change control requests.
• Evaluate supporting documentation, objective evidence, implementation plans, and closure activities to ensure changes are complete and compliant.
• Serve as a primary point of contact for change initiators, providing guidance throughout the change control process.
• Identify and resolve quality or documentation issues and recommend compliant solutions when needed.
• Manage controlled documentation within the Electronic Document Management System (EDMS) in accordance with established policies and procedures.
• Support Document Change Control (DCC) activities and ensure documentation is processed accurately and efficiently.
• Serve as an SME for Quality Documentation and Change Control during internal and external regulatory audits.
• Identify process gaps and opportunities for continuous improvement and help develop solutions.
• Participate in cross-functional site projects and represent Documentation and Change Control on broader initiatives.
• Support Quality leadership with special projects and assignments.
• Provide guidance and direction to other team members as a team lead.
• Balance multiple priorities and deadlines within a fast-paced, regulated environment.

Qualifications

• Bachelor's degree in Business, Management, or a related discipline, or equivalent relevant work experience.
• 5+ years of experience within Quality, Documentation Services, Document Control, and/or Change Control.
• Experience working with a validated document management system and change management system; TrackWise experience is strongly preferred.
• 5+ years of Quality or Change Control experience with an understanding of medical device documentation, including policies, procedures, work instructions, specifications, and related controlled documents.
• 5+ years of experience supporting internal and external audits within a regulated environment.
• Previous experience serving as an SME and providing guidance or training to change initiators and other stakeholders.
• Strong understanding of documentation compliance and change control requirements.
• Excellent organizational and prioritization skills with the ability to manage multiple assignments and deadlines simultaneously.
• Strong written and verbal communication skills, including the ability to clearly explain requirements, identify issues, and recommend solutions.
• Ability to work independently, exercise sound judgment, and make quality-focused decisions with minimal supervision.

What Will Make You Successful
We are looking for someone who combines strong technical knowledge of Quality Documentation and Change Control with the ability to take ownership, solve problems, communicate effectively, and keep critical activities moving forward.
You should be comfortable working across functions, challenging documentation or implementation plans when necessary, and helping stakeholders navigate change control requirements while maintaining compliance.

Key areas of expertise:
TrackWise • Change Control • Document Control • EDMS • Quality Systems • Medical Device Documentation • Regulatory Audits • Quality Compliance • Controlled Documentation • Process Improvement
 


People are our business worldwide
 
Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.