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The Senior CSV Specialist will work as help desk staff for other cross functional teams as appropriate to determine and resolve problems. Respond to queries, isolated problems and determine and implement solutions. Perform daily system monitoring to ensure that all computer-based system will produce information or data that meet predefined requirements.

Requirements

This positions responsibilities will include, but not be limited to the following:

1. Collaborate with system owner to develop URS, Design Qualifications, Functional Requirements, Unit test scripts, UAT scripts, Validation Plans and Protocols, Validation summary report and Traceability matrix
2. Develop procedures specific to GxP Application SOPs and provide SOP review for new systems.
3. Perform Part 11 Assessments for new and existing computer systems
4. Maintain GxP System log and update as necessary
5. Execute the validation protocols, test scripts per Regulatory and GAMP guidance
6. Perform Risk assessments for GxP systems
7. Identify and implement opportunities for continuous improvement related to validation or other compliance practices/issues based on internal compliance issues, industry best practices as well as latest regulatory guidances and regulatory updates
8. Identify, communicate and escalate project and compliance related issues associated with their projects to project Manager/Management
9. Review and assess the impact of new Patches to validated GxP systems and validation of new patches

Benefits

401(k) with matching

Health, Vision, Dental Insurance

Childcare Scholarship

Tuition Reimbursement

Bonus Pay + Merit Increases

Paid Time Off

Flexible Holidays