Documentation Specialist

Program Documentation Specialist I

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

• Supports program managers in the preparation and submission of documents into OCPLM PPM via Change Orders (COs)
• Reviews documents to ensure program-specific information is consistent
• Ensures all program documents contain the appropriate project number and are completed in compliance with existing procedures
• Ensures adherence to site level and corporate SOPs or Work Instructions to comply with ISO Standards
• Uploads all program documents with proper document linking and approvals
• Follows up to confirm that COs are processed successfully and in a timely manner
• Tracks and communicates CO status updates to program managers regularly
• Ensures that all eDDFs(electronic Design and Development File) are organized clearly in a manner consistent with our quality standards

Preferred Minimum Requirements/Qualifications:

• Bachelor’s degree from an accredited college or university.
• 2–3 years of relevant industrial experience.
• Experience working with document change control systems such as Oracle PLM and Documentum.
• Proficiency in Microsoft Office 365 applications and Agile systems.
• Proficiency in Power BI, including creation of dashboards and data visualizations.
• Demonstrated ability to communicate effectively, including the ability to address and appropriately escalate issues.
• Ability to work independently within established procedures and guidelines.
• Strong attention to detail with excellent organizational, verbal, and written communication skills.
• Willingness to collaborate with global teams and build positive internal working relationships.

Nice to Have

• Exposure to Clinical documentation to support regulatory submissions (e.g., 510k, PMA, IVDR, PMDA, NMPA) and related processes.
• Exposure to Instruments, software, consumables, and Reagents development documentation

Experience Level

Mid Level