Contract, Documentation Specialist - Hybrid (Waltham, MA)

Orbis Clinical is seeking a Contract, Documentation Specialist located in Waltham, MA (Hybrid) for 6 months.

Job Title: Contract, Documentation Specialist

Location: Hybrid (Waltham, MA)

Contract: 6 months

Position Summary

The Documentation Specialist will support company's 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

• Review existing documentation with functional owners to confirm current-state accuracy, ownership, applicability, and required updates prior to migration into Propel PLM.
• 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.
• Format, revise, and standardize documents such as SOPs, work instructions, forms, specifications, policies, templates, process maps, and supporting records according to approved company standards.
• Support document metadata preparation, version control, naming conventions, document numbering, change history, and migration readiness activities for Propel PLM.
• Assist in transferring documents into Propel PLM, including upload preparation, document classification, linking to applicable product or process records, and verification of migrated content.
• Coordinate review and approval workflows, follow up with document owners and approvers, and maintain visibility to open actions, blockers, and due dates.
• Identify documentation gaps, obsolete content, duplicate documents, inconsistent terminology, and opportunities to simplify or harmonize documentation across departments.
• Maintain trackers, status reports, migration logs, and document inventories to support project governance and leadership reporting.
• Ensure documentation activities align with applicable quality system expectations, good documentation practices, audit readiness needs, and internal procedures.

Propel PLM Support Scope

• Prepare legacy documents for migration by confirming document owner, lifecycle status, revision level, effective date, approval requirements, and related product or process associations.
• Support Propel PLM document records by verifying document attributes, attachments, linked records, workflow routing, and document accessibility after transfer.
• Work with IT and business process owners to resolve migration issues, data inconsistencies, formatting concerns, and user feedback during deployment.
• Contribute to user guidance, quick-reference materials, and process instructions related to document creation, revision, approval, and retrieval in Propel PLM.

Required Qualifications

• Associate degree or equivalent experience in documentation, quality systems, technical writing, engineering, life sciences, manufacturing, or a related discipline.
• Experience supporting controlled documentation, document control, PLM, QMS, ERP, or other enterprise business systems.
• Strong attention to detail with the ability to identify inconsistencies, formatting issues, missing information, and documentation gaps.
• Proficiency with Microsoft Word, Excel, Outlook, SharePoint, and document management workflows.
• Ability to manage multiple document updates, stakeholders, deadlines, and priorities in a fast-paced project environment.
• Clear written and verbal communication skills, including the ability to follow up professionally with cross-functional contributors and approvers.

Preferred Qualifications

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

Core Competencies

• Documentation accuracy and quality mindset
• Cross-functional collaboration and stakeholder follow-through
• Organization, prioritization, and action tracking
• Process discipline and continuous improvement orientation
• Comfort working with enterprise systems and structured data

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $24.19 - $31.03 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). 

EEO and Reasonable Accommodation Statement:

Stone Harbor Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.