Documentation Specialist III

Two positions available in Branchburg, NJ (100% onsite).

Documentation Specialist II

About the role

Support the development, revision, and maintenance of controlled documentation within a regulated pharmaceutical, biotechnology, or medical device environment. Partner closely with Manufacturing, Engineering, Process Development, Quality, and other cross-functional teams to ensure documentation is accurate, compliant, and maintained according to GMP and quality system requirements.

Responsibilities

• Author, revise, and maintain controlled documents including:
  • Standard Operating Procedures (SOPs)
  • Work Instructions
  • Batch Records
  • Forms
  • Process documentation
• Process documentation through the Electronic Document Management System (EDMS).
• Initiate and manage document-related Change Controls through completion.
• Gather technical information from subject matter experts and convert complex processes into clear, compliant documentation.
• Review documents for formatting, grammar, consistency, and regulatory compliance.
• Collaborate with Manufacturing, Engineering, Quality, CAPA, and Process Development teams.
• Participate in cross-functional meetings and project teams.
• Monitor documentation timelines to ensure changes are completed on schedule.
• Assist with continuous improvement initiatives related to documentation processes.
• Provide guidance on documentation standards and EDMS usage.
• Support regulatory inspections and quality audits.
• Communicate project status and escalate issues when necessary.

Requirements

• Bachelor's degree or equivalent combination of education and experience.
• 3-5 years of technical writing or document control experience in a pharmaceutical, biotechnology, or medical device environment.
• Experience authoring GMP-controlled documentation.
• Experience with Electronic Document Management Systems (EDMS); OneVault preferred.
• Strong Microsoft Word skills including advanced formatting, templates, tables, headers/footers, and document review tools.
• Experience with SAP or other ERP systems preferred.
• Excellent proofreading, editing, and technical writing skills.
• Strong organizational and time management abilities.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities in a fast-paced environment.

Senior Documentation & Change Control Specialist

About the role

Lead complex Quality Documentation and Change Control activities within a regulated manufacturing environment. Serve as the subject matter expert for documentation and change management processes, administering change controls through TrackWise and validated Electronic Document Management Systems while partnering across Quality, Manufacturing, Engineering, and Regulatory functions.

Responsibilities

• Review, evaluate, and process complex Change Controls using validated quality systems.
• Administer change requests through TrackWise and Electronic Document Management Systems (EDMS).
• Review objective evidence, implementation plans, and supporting documentation to ensure compliance.
• Serve as the primary contact and SME for change initiators.
• Evaluate quality issues associated with change requests and recommend compliant solutions.
• Ensure timely completion of Change Controls and associated documentation.
• Support internal, customer, and regulatory audits as the Documentation & Change Control representative.
• Identify process improvement opportunities and implement documentation best practices.
• Participate in site and global quality initiatives.
• Partner with Manufacturing, Engineering, Process Development, and Quality teams.
• Provide training, guidance, and mentorship on documentation and Change Control processes.
• Serve as a team lead by providing direction and support to other Documentation Specialists.

Requirements

• Bachelor's degree in Business, Life Sciences, Engineering, or a related field (or equivalent experience).
• Minimum of 5 years of experience in Documentation Services, Document Control, Quality Systems, or Change Control within a pharmaceutical, biotechnology, or medical device environment.
• Extensive experience using validated Document Management Systems (EDMS).
• Experience administering Change Controls using TrackWise (preferred).
• Experience supporting internal and external regulatory audits.
• Strong understanding of Quality Systems and controlled documentation.
• Experience training users on documentation and Change Control processes.
• Excellent organizational, analytical, and problem-solving skills.
• Strong written and verbal communication skills.
• Ability to prioritize multiple high-priority projects in a fast-paced environment.