What are the responsibilities and job description for the Senior Quality Assurance Documentation and Training Specialist position at SciPro Inc.?
We are thrilled to announce an exciting contract opportunity with our key Biotech client for an initial 6-month contract , with a strong possibility for extension. We are seeking a highly qualified candidate with experience in Veeva Systems and a solid background in GxP Quality Systems training.
The Opportunity :
- Effectively manage and maintain the GxP document control system, including product-related documentation, quality manuals, external documents, departmental procedures, and work instructions.
- Coordinate all aspects of document change controls, ensuring all necessary supporting documentation is provided and that changes are accurately completed and properly closed out.
- Oversee the GxP training program, including assigning training, archiving completed records, monitoring compliance, and conducting regular audits of training records.
- Train new users on the document control and training systems as needed to ensure efficient operation.
- Provide expert guidance on document control practices and procedures across various departments.
- Support the maintenance and enhancement of quality systems processes as required by the organization.
- Ensure strict adherence to company processes, procedures, policies, and GxP standards.
- Generate insightful reports related to document control and training processes, focusing on compliance and quality assurance metrics.
- Collaborate with internal stakeholders and assist QA leadership in resolving and closing any quality issues.
- Perform additional tasks as assigned by management to support the team.
Required Skills, Experience, and Education :
Preferred Skills :
