Reports To: Senior Director, Quality Management
The document specialist perform the activities of document control and quality control, including review of documents, tracking and reporting on document review progress and maintenance of paper file archives and electronic department directories. This position will report to the Senior Director of Quality Management.
Essential functions include but are not limited to the following:
- Manage archival activities for trial master files and other files associated with the conduct of clinical trials, GLP study reports, GMP-mandated documents such as product specifications and batch records and Quality Management files including training records, consultant files and vendor qualification / audit files
- Assist with the implementation, management and administration of the department electronic document management system (EDMS)
- Review and proofread documents for compliance with regulatory requirements, consistency of document format and system concerns including intra- and inter-document consistency
- Maintain library of literature references
- Use department databases to track, manage and control issued documents
- Effectively follow SOPs, policies and GxPs
- Provide support for the Quality System during internal audits
- 5 years pharmaceutical experience
- Experience with good documentation practices
- Knowledge of GxP concepts and guidelines
- Strong communication, prioritization and organizational skills
- Excellent writing skills
- Demonstrated ability to work efficiently and accurately on multiple projects, follow instructions/schedules/timelines and handle shifting priorities
- Bachelor’s degree in science or equivalent
Human Resources
Medivation, Inc.
201 Spear Street
3rd Floor
San Francisco, CA 94105
hr@medivation.com
