Documentation Specialist (CONTRACT - 6 Months)

Documentation Specialist (CONTRACT - 6 Months)

Location: Watertown, MA (Hybrid)

Pay Rate: $25 - 29/hr DOE

Position Summary

The Documentation Specialist will support our 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.

Key Responsibilities

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 Repligen 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.

·        Propel PLM Support Scope

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.

 Required Qualifications

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.
o   Ability to manage multiple document updates, stakeholders, deadlines, and priorities in a fast-paced project environment.
o   Clear written and verbal communication skills, including the ability to follow up professionally with cross-functional contributors and approvers.

 Preferred Qualifications

o   Experience in a regulated life sciences, bioprocessing, biotechnology, pharmaceutical, medical device, or ISO 9001 environment.
o   Familiarity with Propel PLM, Salesforce-based systems, MasterControl, SAP, SharePoint, or other controlled document platforms.
o   Understanding of good documentation practices, revision control, approval workflows, document retention, and audit support expectations.
o   Experience supporting system implementation, data migration, process harmonization, or documentation remediation projects.

·        Core Competencies

o   Documentation accuracy and quality mindset
o   Cross-functional collaboration and stakeholder follow-through
o   Organization, prioritization, and action tracking
o   Process discipline and continuous improvement orientation
o   Comfort working with enterprise systems and structured data
Thank you in advance for your attention and continued support.