What are the responsibilities and job description for the Senior QA Documentation and Training Systems Specialist position at SciPro?
Exciting new contract with our key Biotech client in the Bay Area for an initial 6 month contract, with extension likely. Ideal candidate will be experienced with Veeva Systems and have previous experience in training the GxP Quality Systems...
The Opportunity :
- Manage and maintain the GxP document control system, which includes product-related documentation, quality manuals, external documents, departmental procedures, and work instructions.
- Coordinate all aspects of incoming, in-process, and completed document change controls, ensuring supporting documentation is provided, changes are completed, and documentation is properly closed out and released.
- Oversee and maintain the GxP training program, including assigning training, archiving completed records, monitoring compliance, and conducting periodic audits of training records.
- Train new users on the document control and training systems, as needed.
- Provide guidance on document control practices and procedures to various departments.
- Support the maintenance and enhancement of quality systems processes, as required.
- Ensure adherence to company processes, procedures, policies, and GxP standards.
- Generate reports related to document control and training processes, including training compliance and metrics for QA and other teams.
- Collaborate with internal stakeholders and assist QA leadership in resolving and closing quality issues.
- Perform additional tasks as assigned by management.
Required Skills, Experience, and Education :
Preferred Skills :
