What are the responsibilities and job description for the Document Control Specialist position at BioTalent?
We are partnered with a complex medical device manufacturer seeking a Document Control Specialist to join their team as they release a new product line. You will be working with the document control manager as you work through Change Controls, Trainings, and assist with eQMS implementation.
Key Responsibilities:
- Maintain and manage document control systems in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations.
- Ensure proper documentation creation, review, approval, and archival in an electronic document management system (EDMS).
- Support the administration of change control processes, ensuring proper tracking, review, and implementation of changes to controlled documents.
- Work cross-functionally with Quality, Regulatory, Engineering, and other departments to ensure timely and compliant documentation updates.
- Perform periodic audits of controlled documents to ensure compliance and accuracy.
- Assist in training employees on document control procedures and best practices.
- Support internal and external audits by providing necessary documentation and ensuring compliance with regulatory requirements.
Qualifications:
- Associate’s or Bachelor’s degree in a related field (or equivalent experience).
- 2 years of experience in document control within a medical device, pharmaceutical, or regulated industry.
- Familiarity with ISO 13485, FDA 21 CFR Part 820, and change control processes.
- Experience working with electronic document management systems (EDMS).
Preferred Qualifications:
- Experience with change control processes in a regulated environment.
- Knowledge of risk management principles related to documentation.
- Experience with eQMS transfer.
Salary : $50,000 - $70,000
