Deviation Specialist

Pay Range: $(50.00 – 57.14)/hr on W2 all-inclusive without benefits

Job Description:

• 5 year of experience required for this role

Supporting

Activities:

• Draft Change Requests
• Perform Impact Assessments for Change Requests
• Draft updates to System Impact Assessments
• Draft updates to Master Equipment Inventory
• Draft User Requirements
• Draft Qualification Plans
• Draft Trace Matrices
• Draft Commissioning, Installation and Operational Qualification, and Performance Qualification Protocols
• Execute Commissioning, Installation and Operational Qualification, and Performance Qualification Protocols
• Draft Release Forms
• Draft Handover Reports
• Draft Qualification Reports
• Manage change request actions to ensure completion
• Update actions in change request system
• Communicate with vendors and manage their responsibilities and deadlines
• Collaborate with TSMS, Engineering, Quality, and other teams to verify action items are completed
• Ensure compliance with client and regulatory regulations for commissioning and qualification SOP’s
• Attend cross-functional team meetings to review and report progress
• Identify gaps and provide recommendations
• Maintain compliance with SOP’s and other training
• Support in engineering deviations and compliance activities