Document Control Coordinator
- Req No.
- Job Locations
- Quality Assurance / Regulatory
More information about this job
Would you like to join an innovative team creating technology to power groundbreaking insights in academic, clinical, pharma and biotech research?
It is an extraordinary time for Fluidigm. Our technology is empowering customers to improve life through comprehensive health insight. We invite you to join a leading provider of indispensable life sciences tools that is accelerating global research on multiple frontiers of human health.
At Fluidigm we are also building a positive culture where our people can do the best work of their careers, informed and influenced by our core values:
• Create what customers need next.
• Drive to make a difference.
• Collaborate and learn.
• Step up.
Fluidigm is looking for a Document Control Coordinator. This position works cross-functionally to support efforts to setup and maintain a centralized document management system, maintaining technical file documentation including product, Device Master Records (DMR) and Design History File Design History File) and automated quality training system for Fluidigm Canada. Maintains records management for Quality Systems and is responsible for backup support for Document Control.
• Control and manage execution of documentation Change Orders.
• Control Fluidigm Canada Electronic Quality Management System users’ permissions and access sets.
• Tracks training compliance and reports status of Fluidigm Canada training compliance.
• Processes protocols and reports, scans and uploads document to ComplianceQuest (CQ) eQMS.
• Administrates product’s Device Master Record (DMR), Design History File (DHF) and production Device History Records (DHR).
• Performs filing and scanning of quality system documentation.
• Experience with ISO 13485, ISO 9001 and 21 CFR 820 required.
• Knowledge and experience with administrating Electronic Quality Management System (ComplianceQuest preferred).
• Knowledge and experience with SalesForce.com operation and administration.
• Knowledge of and experience with the following standards: ISO 13485, ISO 14971, ASQ Certification
• 1-2 years of industry experience preferred
• Knowledge in Good Documentation Practices (GDP).
• High school diploma required, Bachelor’s Degree preferred.
• Experience in a pharmaceutical or medical device manufacturing environment desired.
• Knowledge of certification of ISO and GMP regulations desired.
• Experience with electronic documentation & training system a (Very Important) plus
knowledge in ComplianceQuest (CQ), SalesForce.com, Q-Pulse, and Solidworks is preferred.
Ready to join an industry leader with a bold and ambitious mission that is enabling advancements in human health? Apply online with your resume!
Fluidigm is an equal opportunity/affirmative action employer. We will consider all qualified applicants for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.