Karen A. Petraitis

20+ YEARS OF EXPERIENCE

Karen A. Petraitis joined McCrone Associates, Inc. as Quality Assurance Manager in 2023. Karen is responsible for administering the Quality Management System. She collaborates with clients on quality agreements, audits, and other regulatory documentation requirements.

Prior to McCrone Associates, Karen gained over 20 years of GMP compliance experience while in key roles within regulatory affairs, quality assurance and microbiology. As an International Regulatory and Documentation Specialist at Blistex, Inc., Karen played a critical role in preparing documents for international product registrations of cosmetics and healthcare consumables. She has also made significant contributions as a Quality Assurance Associate at Microworks Consulting where she maintained the quality system for the quality control laboratory and coordinated various audits. Furthermore, Karen gained valuable experience as a Microbiology Scientist/Supervisor at America Pharmaceutical Partners (Fujisawa USA, Inc.) where she performed USP release and stability testing on injectable drugs in aseptic cleanroom environments.