Documentation Specialist

Documentation Specialist (Contract)

Location: Waltham, MA (hybrid)

Duration: 6 months

Rate: 25-29/hr

Position Summary

We are seeking a detail-oriented Documentation Specialist to support a documentation modernization initiative and Product Lifecycle Management (PLM) system implementation. This individual will partner with cross-functional teams to review, update, standardize, and migrate controlled and business-critical documentation into a new PLM platform.

The Documentation Specialist will help ensure documentation is accurate, complete, traceable, properly formatted, and compliant with quality and regulatory requirements in a regulated manufacturing environment.

Key Responsibilities

Documentation Management

• Review existing documentation with functional owners to verify accuracy, ownership, applicability, and required updates before migration into the PLM system.
• Collaborate with Quality, Regulatory, Engineering, Manufacturing, Product Management, Supply Chain, Commercial Operations, IT, and other stakeholders to gather information and facilitate timely document updates.
• Format, revise, and standardize documents including:
• • Standard Operating Procedures (SOPs)
  • Work Instructions
  • Forms
  • Specifications
  • Policies
  • Templates
  • Process Maps
  • Supporting Records
• Apply approved document standards and ensure consistency across documentation.
• Prepare document metadata and support version control, naming conventions, document numbering, change history, and migration readiness activities.
• Coordinate document review and approval workflows, manage follow-ups with stakeholders, and track outstanding actions and deadlines.
• Identify documentation gaps, duplicate records, obsolete content, inconsistent terminology, and opportunities for process improvement.
• Maintain project trackers, migration logs, status reports, and document inventories to support project governance and reporting.
• Ensure all documentation activities align with established quality system requirements, documentation best practices, and audit readiness expectations.

PLM System Support

• Prepare legacy documents for migration by validating document ownership, lifecycle status, revision levels, effective dates, approval requirements, and associated products or processes.
• Support document migration activities including document preparation, classification, linking of related records, and post-migration verification.
• Partner with IT and business process owners to resolve migration issues, data inconsistencies, formatting concerns, and user feedback during implementation.
• Assist in developing user guidance materials, quick-reference documents, and process instructions related to document creation, revision, approval, and retrieval within the PLM environment.

Required Qualifications

• Associate degree or equivalent experience in Documentation Management, Quality Systems, Technical Writing, Engineering, Life Sciences, Manufacturing, or a related discipline.
• Experience supporting controlled documentation, document control processes, PLM, QMS, ERP, or other enterprise business systems.
• Strong attention to detail and ability to identify inconsistencies, formatting issues, missing information, and documentation gaps.
• Proficiency with Microsoft Office applications, including Word, Excel, Outlook, and SharePoint.
• Ability to manage multiple priorities, deadlines, stakeholders, and document updates in a fast-paced project environment.
• Strong written and verbal communication skills with the ability to work effectively across departments.

Preferred Qualifications

• Experience within a regulated manufacturing, life sciences, biotechnology, pharmaceutical, medical device, or ISO-regulated environment.
• Familiarity with PLM platforms, document management systems, ERP applications, SharePoint, or similar enterprise systems.
• Knowledge of document control practices, revision management, approval workflows, document retention requirements, and audit support activities.
• Experience supporting system implementations, documentation remediation efforts, process harmonization initiatives, or data migration projects.

Core Competencies

• Documentation accuracy and quality focus
• Cross-functional collaboration
• Organizational and project coordination skills
• Attention to detail and process discipline
• Continuous improvement mindset
• Ability to work with structured data and enterprise systems

Job Type: Contract

Work Environment: Fast-paced, collaborative environment supporting documentation modernization and digital transformation initiatives within a regulated industry.