EOY Contract with the possibility for conversion for the right associate.
As an associate in quality, you will lead the review of various validation and qualification documents, ensuring compliance with quality standards. Your responsibilities include overseeing commissioning, validation, and qualification activities, managing change controls, investigations, and CAPAs, and participating in internal and external cGMP audits. You will also prepare and review SOPs, Annual Product Reports, and specifications for new packaging and manufacturing components.
Requirements:
· Bachelor of Science degree in Natural Sciences, and / or Engineering
· 5+ years of GMP Quality Assurance, Manufacturing, Technical Services, or Validation experience in medical device, pharmaceutical or biopharmaceutical industry
· 5+ years executing and / or reviewing Process Validation, Cleaning Validation, Computer Validation, Equipment / Utilities Qualification, Commissioning, and Method Validation documentation.
· Demonstrated ability to interpret cGMP, 21CFR 210 and 211, other applicable regulations, standards and guidance.