Senior QA Analyst

Position: Senior QA Analyst


Location: Ardsley, NY


Duration: 6+ Months

• 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

• 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