I’m a pharmaceutical and medical device manufacturing and Quality Assurance professional. I’d love to connect with you send me a message Specializations: Quality Audits, team building, manufacturing improvement and remediation.
History of successful Audits across all Regulatory agencies – Certified auditor in the biomedical industry with expertise in leading teams to exceed goals and coaching individual contributors to reach new levels of excellence.
Extensive experience in setting up Quality systems as well as remediation of Quality systems and manufacturing processes which have been determined to be high risk.
Talented at creating environments that drive teamwork and inspire new levels of learning and excellence.
Skilled in hiring and coaching new professionals on manufacturing procedures and Quality based concepts for process improvement, cost reduction, and safe drug product manufacturing.
Specialties: Audit preparation for regulatory agencies (FDA, NRC), Audits for process checks and process improvement (CBA- Certified Auditor), cGMP practices, Operating procedure improvements, coach based training, Goal oriented – cross functional teams.
Lately I’ve been working toward another degree and this one is in Cybersecurity. I have earned several IT certifications on this journey so far and am looking to bring unique perspectives with my background in root cause analysis and cross functional team facilitator.