Contract position: A leading biomedical organization located in Rockville, MD is looking for a Document Control Specialist. This is a 6 month contract opportunity. APPLY NOW!
Responsibilities for the Documentation Control Specialist
- Responsible for providing critical support, guidance and management of Quality Management System and Regulatory Affairs related documentation and records, including production, labeling and distribution related records.
- Be a subject matter expert (SME) regarding good documentation practices (GDP) and documentation requirements to support and demonstrate compliance to applicable medical device regulatory requirements (e.g. US QSR, ISO 13485 QMS, etc.).
- Working knowledge of the requirements of electronic records and signatures as well as a solid understanding of the differences in documentation requirements between Design Control records and Production documentation.
- Contributes to and participates in the implementation of Document and Change Control processes and systems for compliance to applicable medical device QMS and regulatory requirements.
Requirements for the Documentation Control Specialist
- BS degree required
- 3+ years of working experience in a Document Control or administrative Quality role in a regulated field.
- Work experience in medical devices, in-vitro diagnostics, molecular diagnostics or related industries. a plus
- Working Knowledge of 21CFR Parts 11 and 820, and ISO 13485 QMS.
- Prior experience with and understanding of Good Documentation Practices (GDP)
- Comprehensive benefit package