Job Description:
Client is looking for an Analytical Validation specialist to lead validation activities including, but not limited to, software updates, new system introduction, and decommissioning of analytical systems. This is a CSV role as instruments have software components so well rounded QC Lab CSV expertise is what we are looking for. Instruments such as: TOC Analyzer, HPLC, MassSpec, Cell Counters, Empower, etc. Looking for candidates who have exposure to KNEAT validation as well.
Responsibilities:
- Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of analytical equipment.
- Drive/own the validation plans and execution of analytical equipment changes and process improvements.
- Execution of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.
- Own all forms of TW records including CC/CAPA/Deviations to support project completion.
- Generating User Requirements Specification Documentation, complete Electronic Records/Electronic Signatures, Data Integrity Risk Assessments and Audit Trail Risk Assessments.
- Review analytical equipment, manuals, and devise validation plans
- Procurement of Analytical Equipment which includes ensuring system meets specifications, quotes, budgets and installations.
- Analytical Equipment Ownership
- Identify Quality Issues, involve stakeholders, drive to completion/resolution
- Participate on Risk Assessments
- Review/Approve Commissioning Qualification Validation Documents
- Perform other duties as assigned.
Skills:
- QC, System, Validation, Lab, Empower, HPLC, CSV, Analytical
Education:
- B.S. Degree in relevant field preferred.
NH: Analytical Validation Specialist (237350)
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