Support the analysis of customer complaints including coordination of activities with customers, detailed failure analysis, and reporting to customer using customer portals.
October 02, 2022
Manage all aspects of quality systems, such as documentation, trainings, change controls, quality agreements and computer system validations as necessary for complaint handling.
December 28, 2022
Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives.
February 02, 2023
Manages QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
February 04, 2023
Participate in external and internal regulatory audits and regulatory processes as required for matters related to Complaints and Regulatory.
March 22, 2023
Provide expertise and guidance in interpreting global governmental regulations, agency guidelines and internal procedures related to product complaints, product recall and records management to assure continued compliance across all Cell Therapy GMP operations.
April 07, 2023
Leading the clinical quality audiologist team in making determinations as to potential reportability of complaints to regulatory agencies globally, and collaborating with Regulatory Affairs and global Field Staff to ensure appropriate information is collected for reportability.
April 08, 2023
Review completed complaint files to ensure compliance to business requirements as well as regulatory requirements.
April 25, 2023
