Position: Senior QA Analyst Location: Ardsley, NY Duration: 6+ Months Note: Must be local - Face to Face interviews are required Required: 5-10+ Years: Computer System Validation 2-4+ Years: BIO/Pharmaceutical industry experience Experience with equipment controlled by ERP, LIMS, EMS, PMS, and other Quality and Development Laboratory systems. Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11, Part 820, and GAMP standards are required. Process Validation CQA Calibration, Manufacturing Equipment Software Validation Must understand Manufacturing Line and Operational Excellence in Production Environment utilizing Software that validates equipment Solid understanding of Good Manufacturing Practice Root cause analysis; experience investigating and troubleshooting automation and control systems Background in Engineering Ability to work in cross-functional team environments, as well as independently, and to work multiple and competing projects Strong written and verbal communication skills Knowledge of MS Office, SharePoint, MS Project, and Visio. Must be local - Face to Face interviews are required Desired: Knowledge/familiarity with U.S. and Global regulatory registration of drug products is preferred. International, cross culture, and cross functional experience desired Project management skills ISO-13485:2016 knowledge and experience Thanks