QA Engineer

Position: QA Engineer
Location: Raritan, NJ (Hybrid) Duration: 6-12 Months+

Tax: W2 Only

• They need someone who can work onsite 2-3 days a week in Raritan, NJ.
• For this role, they prefer someone who has exp with AI, gen AI, machine learning, and LLMs.

In addition to validation and regulation experience, the resource should have the following experience:

• Experience with GenAI and Agentic AI is necessary.
• Onshore US or Nearshore 3-7 years of relevant experience; can work independently and guide/mentor Junior resources.
• Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation
• Experience in FDA and/or Global regulated environment with a good understanding of GxP standards and risk-based validation.
• Knowledge of FDA guidance and industry standards (i.e., GAMP)
• Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports, and Compliance/Validation Reports
• Experience in reviewing system test and user acceptance test scripts, Traceability matrix, and Design Specs.
• Experience in QA Methodologies, designing, reviewing, and approving Test Plans, systems, and UAT test scripts and Test procedures.
• Ability to Review Automated Test script
• Strong verbal and written communication skills.
• Ability to work as a team player, lead a team, or accomplish tasks without supervision.
• Ability to work with remote teams and support several changes/projects simultaneously.
• Ability to provide Validation guidance, timely reviews, and escalations to TQ management.
• Hands-on experience with the validation of Data Solutions is preferred.