Bretta Skinner

About Bretta Skinner

Myers-Briggs: INFJ (Creative; Passionate; Empathetic; Orderly) Experienced quality…

Experience

1. Quality Assurance Specialist

   Alnylam Pharmaceuticals

   Sep 2022 — Present

   Monitor the global product complaints inbox • Manage and document thorough and accurate complaint records while ensuring they are processed in a uniform and timely manner. • Ensure complaint records and applicable complaint handling documents are compliant with Good Documentation Practices (GDocP) • Responsible for assuring all product quality complaints are appropriately initiated in the Veeva Quality Management System (QMS). • Interface with Medical Information Call Center and Global Patient Safety and Risk Management to obtain information regarding product feedback and complaints. • When necessary, call and/or write the complainant to obtain additional information such as lot number and expiry date. • Prepare customer communication (response letters, acknowledgement letters) as appropriate. • Perform internal and external communications including notification of new complaints and status of critical investigations. • Own product complaints, including the classification of received complaints and management of investigation activities with internal and external participants. • Perform weekly and monthly reconciliations with drug safety/affiliates. • Compile and provide metrics on post market data for forums such as Quality Management Review and Postmarket Surveillance forums • Support Product Recall and Product Withdrawal activities • Provide a customer focused attitude when interacting with internal stakeholders • Propose and implement process improvement initiatives • Receive and inspect return samples as needed to support complaint investigations • Maintain relationship with Combination Product stakeholders