Waltham, MA
6 month contract
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The Documentation Specialist will support documentation modernization and Propel PLM implementation by partnering with impacted departments to review, update, standardize, and transfer existing controlled and business-critical documentation into the Propel PLM system. This role will help ensure that documentation is accurate, complete, properly formatted, traceable, and ready for use in a regulated bioprocessing environment.
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o Review existing documentation with functional owners to confirm current-state accuracy, ownership, applicability, and required updates prior to migration into Propel PLM.
o Partner with impacted departments, including Quality, Regulatory, Engineering, Manufacturing, Product Management, Supply Chain, Commercial Operations, IT, and other stakeholders, to gather input and drive timely document updates.
o Format, revise, and standardize documents such as SOPs, work instructions, forms, specifications, policies, templates, process maps, and supporting records according to approved standards.
o Support document metadata preparation, version control, naming conventions, document numbering, change history, and migration readiness activities for Propel PLM.
o Assist in transferring documents into Propel PLM, including upload preparation, document classification, linking to applicable product or process records, and verification of migrated content.
o Coordinate review and approval workflows, follow up with document owners and approvers, and maintain visibility to open actions, blockers, and due dates.
o Identify documentation gaps, obsolete content, duplicate documents, inconsistent terminology, and opportunities to simplify or harmonize documentation across departments.
o Maintain trackers, status reports, migration logs, and document inventories to support project governance and leadership reporting.
o Ensure documentation activities align with applicable quality system expectations, good documentation practices, audit readiness needs, and internal procedures.
o Prepare legacy documents for migration by confirming document owner, lifecycle status, revision level, effective date, approval requirements, and related product or process associations.
o Support Propel PLM document records by verifying document attributes, attachments, linked records, workflow routing, and document accessibility after transfer.
o Work with IT and business process owners to resolve migration issues, data inconsistencies, formatting concerns, and user feedback during deployment.
o Contribute to user guidance, quick-reference materials, and process instructions related to document creation, revision, approval, and retrieval in Propel PLM.
o Associate degree or equivalent experience in documentation, quality systems, technical writing, engineering, life sciences, manufacturing, or a related discipline.
o Experience supporting controlled documentation, document control, PLM, QMS, ERP, or other enterprise business systems.
o Strong attention to detail with the ability to identify inconsistencies, formatting issues, missing information, and documentation gaps.
o Proficiency with Microsoft Word, Excel, Outlook, SharePoint, and document management workflows.