Patricia Sobolewski Asq Cqa, Cmq/Oe
About Patricia Sobolewski Asq Cqa, Cmq/Oe
Patricia Sobolewski is the Associate Director of Quality Systems at Applied DNA Sciences, where she has worked since 2020. With extensive experience in quality management and regulatory compliance, she has held various roles in the pharmaceutical industry, including Senior Quality Systems Manager and GMP Trainer.
Current Role at Applied DNA Sciences
Patricia Sobolewski serves as the Associate Director of Quality Systems at Applied DNA Sciences, a position she has held since 2020. In this role, she oversees the implementation and management of quality systems, ensuring compliance with regulatory standards. Her responsibilities include managing Corrective and Preventive Actions (CAPA) and Change Control processes, which are critical for maintaining product quality and safety.
Previous Experience at Applied DNA Sciences
Prior to her current role, Patricia Sobolewski worked at Applied DNA Sciences as the Senior Quality Systems Manager from 2014 to 2020. During her six years in this position, she contributed to the development and enhancement of quality management practices within the organization, focusing on compliance with industry regulations and standards.
Career Background in Quality Management
Patricia Sobolewski has extensive experience in quality management, having worked at Nycomed US Inc as a GMP Trainer from 2005 to 2011. She also spent 20 years at Bristol-Myers Squibb as a Finished Product Supervisor from 1984 to 2004. Her background includes training personnel on Good Manufacturing Practices (GMP) and supervising the production of finished pharmaceutical products.
Education and Certifications
Patricia Sobolewski earned a Bachelor of Science degree in Biology with a minor in Chemistry from Alvernia College. She holds certifications in Quality Auditing and Quality/Organizational Excellence, which reflect her commitment to maintaining high standards in quality management. Her educational background supports her expertise in implementing effective quality systems.
Expertise in Regulatory Compliance
Patricia Sobolewski possesses in-depth knowledge of regulatory requirements, including 21 CFR Parts 11, 58, 210, 211, and 820. She is experienced in managing compliance with ISO 9001 and ISO 17025 standards, which are essential for ensuring quality and reliability in laboratory and manufacturing processes. Her expertise in these areas enhances her effectiveness in quality system management.