SUMMARY OF SKILLS
A dynamic quality and regulatory specialist with over 7 years experience in managing customer complaints and control of regulatory documents . Professional experience entails substantial knowledge of medical device and the pharmaceutical industry including regulations such as 21 CFR Part 820; ISO 13485, ISO 14971.
PROFESSIONAL EXPERIENCE July 2012 - Present
Takeda Pharmaceuticals, (Agency, Randstad Pharma) Deerfield, IL
Quality Investigator
• Review individual complaints for quality assurance and associated service data to determine risk level and complete investigation.
• Review CAPA’s and report for tracking and trending. Analyze and measure deviations.
• Liaison with suppliers to facilitate the completion of product complaint investigations and ensure that investigation reports are completed in a timely manner.
• Lead and participate in meetings and projects to communicate and resolve system and quality issues tied to product complaints. Use MEDIsource and TrackWise electronic systems.
• Interface with Pharmacovigilance, product specialists and customer service department to ensure timely resolution and evaluation of complaints.
Abbott, Abbott Park, IL (Agency, Cortech) January 2012 – March 2012
Informational Specialist III, Quality & Regulatory
• Worked on short-term assignment to Review FDA inquiries and complete investigative studies
• Provided analysis and clinical documentation for external distribution
• Reviewed medical/scientific literature, 483’s and warning letters to maintain awareness of relevant product information.
• Maintained the Quality Affairs website and participated in internal and external audits.
United Airlines, Chicago, IL May 2011 – January 2012
Customer Support
• R...
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