Jeanette Johnson has spent over 20 years working in FDA regulated industries. She has experience, domestic and international, in areas of complaint handling and investigations and development, implementation and leading of classroom and web based customer technical training. She has extensive knowledge of quality systems, documentation and regulatory requirements related to customer complaint, root cause investigations, corrective and preventive actions. Jeanette earned her BS in Biology from James Madison University, and her Master of Science in Bioscience Management from George Mason University.
Ms. Johnson is a seasoned professional with over 25 years of experience in the pharmaceutical and medical device industries working in GLP, GMP, ISO and DEA regulatory environments. She is skilled in the development, implementation, maintenance and continuous improvement of various Quality Management Systems that include Audits & Inspections, Document Management, Change Management, Risk Management, Corrective and Preventive Action and Effectiveness programs, Deviations and Investigations, Complaint and MDR Handling, Supplier Qualification, Data Integrity and Quality System Management Metrics and Trending. Ms. Johnson has held positions in Analytical Research, Regulatory Affairs and Quality Assurance within multinational and virtual companies, such as Bristol Myers Squibb, Wyeth-Ayerst, Purdue Pharma, Watson and Pharmaceutics International, Inc. Ms. Kimberly Johnson is a certified A.S.Q Quality Auditor, is currently obtaining her Master’s Degree in Quality and Regulatory Affairs from Temple University and has a B.S. in Chemistry from the State University of New York at Oswego.
Monica is an experienced professional with over 15 years of knowledge in numerous compliance and quality assurance scenarios. She is proficient in project management, problem solving, auditing, SOP development, training and regulatory compliance, including cGMPs, 21CFR Part 11, and ISO 9000. She has worked in cross-functional team leadership across all levels of organizations. Monica is accomplished in Process Validation within the Pharmaceutical and Medical Device industries. Monica earned her Bachelor in Industrial Engineering from Rutgers University. She is also an ASQ Certified Auditor and ASQ Certified Quality Engineer.
Quality System Consultant
Nola Benstog is a diversified professional with a thorough knowledge of Quality Management Systems. She has over sixteen years of experience in the areas of Quality Assurance, Quality Control, Regulatory Affairs, Validation and Sterilization in both industry and consulting roles. She has worked in the medical device, pharmaceutical, combination product and nutritional supplement industries with experience ranging from start-ups to Fortune 100 and 500 companies. She began her career as a Technician in a Microbiology Lab and has held various positions up to the Executive Management level throughout her career. Nola received a Bachelor of Science in Microbiology from Weber State University and a Master of Business Administration from Utah State University. She has been an American Society for Quality (ASQ) Certified Quality Auditor (CQA) since 2007.
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