Ashley Seal
Derby,KS
Summary
Seasoned Quality Professional with extensive experience in Supplier Quality Operations, Manufacturing Quality, and Incoming Quality within the pharmaceuticals industry. Trained in quality assurance and project management, adept at implementing cGMP standards and supplier quality procedures. Skilled in exception/event report writing and effective time management, driving compliance with regulatory requirements and advancing industry standards.
Overview
13
13
years of professional experience
Work History
Supplier Quality Engineer
Pfizer, Inc.
McPherson, KS
10.2019 - 10.2024
- Subject Matter Expert (SME) for Secondary Packaging Material (SPM) Suppliers
- Benchmark with other Pfizer sites to align SPM processes
- Supplier Corrective Action Requests (SCARs)
- Ongoing process improvements, standardization, and daily coordination for SCARs
- Other additional communication with Suppliers
- MSQA/RQA Site Auditor Trained
- Ongoing duties for Supplier Qualifications, Quality Agreements and Periodic Supplier Reassessment in addition to supporting new products and projects
- Support the initiation of new Quality Agreements (QA) (and amendments to existing QA’s) with Suppliers
- Provide support to the Site Self Audit (SSA) group
Quality Operations Professional
Pfizer, Inc.
McPherson, KS
02.2018 - 10.2019
- Provided real time Quality impact and decisions (24/7)
- Supported the writing of Event Reports (ERs)
- Supported the investigation of QARs
- Reviewed and Approved for Quality for Validation Reports for Equipment and Component Preparation Areas
- Assessed potential Regulatory impact on a Global basis
- Participated in Quality Alert Records (QAR) GEMBAS
Manufacturing Quality (MQ) Supervisor
Pfizer, Inc.
McPherson, KS
12.2017 - 02.2018
- Completed training when the new Quality Operations role was implemented
Incoming Quality (IQ) Engineer
Pfizer, Inc. / Hospira
McPherson, KS
02.2012 - 12.2017
- Project Lead on Tailgate Qualifications
- Investigation writing
- Event Reports (ERs)
- Supplier Corrective Action Requests (SCARs)
- Other additional communication with Suppliers
- Monthly / Annual Logbook Review
- Monthly Supplier Metrics
- Component Holds
- Department document revisions
- Participated in Supplier Audits
- Staples/Taylor Communications
- Wichita, Kansas
- West Pharmaceutical Services
- Kearney, Nebraska
- Participated in Lab tours for Audits as a back up
- Customers
- Regulatory
Education
Project Scheduling & Cost Management -
McPherson05.2017
B.S. - General Studies, Emphasis in Sociology
Wichita State University
12.2010
Skills
- Current Good Manufacturing Practices (cGMPs)
- Microsoft Office Suite
- Microsoft Power Platform
- Microsoft Excel
- Supplier Management System (SMS)
- Quality Tracking System (QTS)
- JDEdwards
- Project Management
- Visio
Courses and Seminars
Project Scheduling and Cost Management, McPherson, KS - 05/04/2017
Supplier - CCL Label Packaging University Training, Toronto, Canada - 9/25-28/2023
References
References available upon request.
Timeline
Supplier Quality Engineer
Pfizer, Inc.
10.2019 - 10.2024
Quality Operations Professional
Pfizer, Inc.
02.2018 - 10.2019
Manufacturing Quality (MQ) Supervisor
Pfizer, Inc.
12.2017 - 02.2018
Incoming Quality (IQ) Engineer
Pfizer, Inc. / Hospira
02.2012 - 12.2017
Project Scheduling & Cost Management -
B.S. - General Studies, Emphasis in Sociology
Wichita State University