Jt764 - Validation Specialist

• Perform and/or review process validation [PV: characterization, OQ, PQ] (not cleaning process) and equipment qualification [CSV: URS, FAT, IQ, OQ, PQ, TMV] (not laboratory).
• Experience in production line.
• Basic knowledge in defining validation strategies (e.g. requirements flow down from design to manufacturing).
• Experience with Risk Management documentation: pFMEAs.
• Basic knowledge in statistics (preferably using Minitab).
• Experience with projects: design requirements validation, manufacturing controls (not Operational Excellence).

• Bachelor's degree in Science or related area.
• Minimum of 2 years of related experience.
• Knowledge in Medical Devices regulations.
• Experience in GMP documentation.
• Experience investigating manufacturing operations events in support to product disposition​.
• Experience assessing and tracing manufacturing defects/rejects trends​.
• Experience working and executing Design transfer activities.
• Must be available to work all shifts, weekends and overtime.
  • Availability to work extended shifts (8- 12 hours per shift)

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.