Microsoft Office
Morgan Yakich
Sr. Specialist Quality Assurance, CAPA
Keller,TX
Summary
Self-motivated, reliable, and hard-working team player who is driven to achieve goals, take on new challenges, and learn and develop new skills. A Sr. Specialist QA with several years experience supporting the CAPA team and Transfusion organization through nonconformance processing, leading cross functional investigations, supporting process improvements and audit support.
Overview
13
13
years of professional experience
3
3
years of post-secondary education
Work History
Quality Assurance Supervisor
Abbott Laboratories
11.2023 - Current
- Organized and tracked the release of parts and documentation to support product development
- Collaborated with project management to determine prioritization and business needs
- Oversaw onboarding and training of new employees to meet project demands
- Developed and maintained tracking tool to monitor status and track timeline
- Presented weekly status and projected targets to senior leadership
- Scheduled and monitored team assignments based on priorities
Sr. Specialist Quality Assurance, CAPA
Abbott Laboratories
07.2022 - Current
- Serves as CAPA Review Board (CRB) for site nonconformance and investigation records
- Schedules and maintains oversite of team queue to ensure prioritization and meet site demand
- Presents elevation topics to senior leadership to provide oversight of current product and supply issues
- Provides guidance and support to fellow team members to ensure quality documentation and timely record closure
- Generates and presents metrics to support team communication and provides visual indicators to current state
- CAPA trainer who provides guidance and support to organizational team members
- Completed developmental training to serve as CAPA Subject Matter Expert (SME)
- Supports evaluation and documentation of nonconformances and investigation records
Specialist Quality Assurance, CAPA
Abbott Laboratories
12.2019 - 07.2022
- Support evaluation and documentation of approximately 5 nonconformances per month within the Trackwise Database
- Leads investigation cross functional team meetings to support determination of root cause, and identification of corrective actions.
- Maintains oversight of personal queue to support timely implementation of action plans and completion of status reports
- Provides audit support through serving as scribe and or CAPA request designee
- Coordinates and presents product elevations to site leadership to support determination of next steps
Material Handler
Collins Aerospace
06.2019 - 11.2019
- Maintained inventory management through cross functional team communication, analysis of production demand and shortage risk.
- Demonstrated strong communication skills via serving as liaison to senior management for status of materials
Lead QC Analyst-Instrument Specialist
Allergan Pharmaceuticals
02.2012 - 08.2018
- Served as team leader driving consistent, on-time release of raw materials to meet production schedule
- Investigated test failures to determine root cause through use of quality tools, e.g. fish bone diagram, 5 Whys, 6Ms
- Laboratory raw materials subject-matter-expert (SME) in internal and external audits
- Served on lead team implementing lean processes for laboratory
- Performed troubleshooting and failure analysis associated with instrument malfunctions in laboratory
- Spear-headed qualification of new instruments
Education
Bachelor of Science - Biology
Baylor University
Waco, TX 01.2009 - 12.2011
Accomplishments
2020 Site Director Award
2022 Dallas Business Challenge
Yellow Belt Recipient
Software
Trackwise
Solutions Business Manager
SAP
Timeline
Quality Assurance Supervisor
Abbott Laboratories
11.2023 - Current
Sr. Specialist Quality Assurance, CAPA
Abbott Laboratories
07.2022 - Current
Specialist Quality Assurance, CAPA
Abbott Laboratories
12.2019 - 07.2022
Material Handler
Collins Aerospace
06.2019 - 11.2019
Lead QC Analyst-Instrument Specialist
Allergan Pharmaceuticals
02.2012 - 08.2018
Bachelor of Science - Biology
Baylor University
01.2009 - 12.2011
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