QMS & SAP Validation Analyst (Contract)
Position Type: Contractor / Consultant – FTC (6-9 Months with possible extension)
Location: Piscataway, NJ (onsite - physical presence required) – OR – Chicago, IL (onsite - physical presence required)
Reports To: Sr. Director of IT
Rate: $65–$75/hour, not overtime eligible
Work Authorization: Must be authorized to work in the U.S. without sponsorship, now or in the future
Position Summary
We are seeking a Validation Analyst to support validation of our Quality Management System (MasterControl) and SAP implementation (QM, Materials Management, Production modules). This role works under the direction of a senior validation lead and partners with Quality, IT, and business functions to deliver validation artifacts in compliance with 21 CFR Part 11, GxP, and EMA expectations.
Essential Duties & Responsibilities
- Support validation of MasterControl QMS - authoring and executing IQ/OQ/PQ protocols, traceability matrices, and validation summary reports
- Support SAP implementation and validation activities across QM, MM, and PP modules, including test script authoring and execution under senior oversight
- Contribute to risk assessments, data integrity assessments, and change control documentation
- Liaise with QA, IT, business process owners, and external SAP implementation partners
- Support periodic review and maintenance of validated state for assigned systems
- Assist in audit and inspection readiness for MasterControl and SAP