Colleen Divora

About Colleen Divora

Quality Professional with experience in the medical device and pharmaceutical industry in Quality Assurance, Quality Control and Manufacturing Operations. Manage sight wide Quality programs including: deviation, customer complaints, training, supplier approval/audits, customer/vendor quality agreements and change control. Extensive writing experience including: change controls, design plans, authoring new SOPs, internal/supplier audit reports and investigation/out of specification reports. Experienced in providing group and site wide training sessions.

Experience

1. Associate Director Quality Assurance

   AbbVie

   May 2020 — Present · Waco, TX, US

   I lead the Customer Complaints, Non-Conformance and CAPA investigation teams at the Waco facility. I am focused on improving investigation root cause analysis and identifying the true root cause of Non-conformance to reduce the number of repeat events. I have placed an emphasis on reduction of Human Error related non-conformances by organizing instructor led training drilling into the different types of human error and providing tools to better aid in identification and corrective/preventive actions to take when root cause of human error is identified. In a 6 month timeframe, human error related Non-conformances have been reduced by 51% with the training and tools that have been implemented.

Education

• University of Illinois

  Bachelor's degree, Biology, General

Skills

• Standard Operating Procedure (Sop)
• Cross-Functional Team Leadership
• Laboratory
• Supplier Quality
• U.s. Food and Drug Administration (Fda)
• Quality System
• Internal Investigations
• Cold Forming
• Product Complaints
• Quality Assurance
• Medical Devices
• Capa
• Pharmaceutical Industry
• Sop
• Fda
• Clean Rooms
• Dea
• Trackwise
• Change Control
• Management of Change
• Microbiology
• Validation
• Blister Packaging
• Vendor Audit
• Aseptic Processing
• Training
• Quality Control
• Gmp
• Sop Authoring
• Thermoforming
• Vitek