The C&Q Specialist will support equipment qualification activities under the direction of senior project staff.
- Prepare and update qualification documentation in Kneat, including URS, qualification protocols, qualification reports, Annex 11, Part 11, EHS assessments, OOP risk assessments, BCAL forms, and related records, in alignment with J&J AIQ categories.
- Execute assigned qualification tasks based on J&J AIQ classifications and approved vendor-supplied qualification packages, following established procedures and guidance.
- Support oversight activities for vendor-executed qualification work by assisting with document review, execution evidence checks, and report compilation.
- Assist with the documentation and tracking of deviations identified during qualification activities, including supporting impact assessments and resolution actions as directed.
- Support routing of qualification assessments, protocols, and reports through established review and approval workflows.
- Assist with equipment receipt, inspection, and documentation activities in coordination with the Documentation Logistics Specialist, as needed.
- Ensure assigned qualification documentation is accurate, complete, traceable, and organized in an inspection-ready manner.
- Apply foundational equipment qualification or laboratory experience to support timely execution of assigned tasks and overall project readiness.