Job Description
The Documentation Specialist is responsible for maintaining accurate, up-to-date documentation in compliance with regulatory standards and internal quality requirements.
Responsibilities :
- Ensure that all documents are up to date, accurate, and in compliance with relevant regulatory standards.
- Assist in the creation of documents for product specifications, protocols, and history files.
- Assist in internal audits and document reviews to ensure compliance with regulations
- Ensure all documentation aligns with internal quality systems and external regulatory requirements.
- Collaborate with cross-functional teams to manage document control processes and improve documentation workflows.
Requirements
Bachelor's degree in a relevant field (e.g., Manufacturing, Engineering, Sciences, Business Administration, etc.).5 years of experience with a focus on documentation or regulatory compliance in the pharmaceutical or medical device industry.Bilingual (English & Spanish, written and spoken)Technical Writing