Ashley Cunningham (Menigoz)
Saint Anne
Summary
To drive process improvement by reducing waste, solving complex operational challenges, and supporting cross-functional teams through collaboration and continuous improvement.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Investigation Owner
CSL Behring
Bradley, IL
04.2022 - Current
- Lead end-to-end GMP investigations for deviations, nonconformances, and quality events, ensuring timely closure and full compliance with CSL Behring Quality Systems and global regulatory expectations.
- Conduct detailed root cause analyses using 5 Whys, Fishbone, Fault Tree Analysis, and data trending to identify true root causes and prevent recurrence.
- Author clear, audit-ready investigation reports with strong problem statements, evidence-based conclusions, and defensible rationale aligned with FDA, EMA, and other regulatory standards.
- Own CAPA development and execution, ensuring corrective and preventive actions are measurable, sustainable, and verified for long-term effectiveness.
- Collaborate cross-functionally with Manufacturing, Quality Control, Engineering, Validation, and Supply Chain to gather evidence, align on root cause, and drive resolution of complex quality issues.
- Assess product impact and patient risk, supporting batch disposition decisions through data review, SME consultation, and quality risk management principles.
- Support internal and external audits by presenting investigation details, CAPA effectiveness, and historical trends; respond to auditor questions with clarity and confidence.
- Identify systemic issues through trend analysis and drive continuous improvement initiatives to strengthen process robustness and reduce deviation recurrence.
- Ensure documentation accuracy and data integrity within TrackWise (or applicable QMS), maintaining traceability and compliance with cGMP and internal quality standards.
Animal Care Technician
Charles River Laboratories
Chicago, IL
09.2020 - 03.2022
- Maintained accurate records of animal health, behavior, and environmental conditions using specialized software systems.
- Implemented improvements in sanitation procedures, enhancing overall cleanliness of animal housing facilities.
- Collaborated with veterinary staff to develop and execute treatment plans for medical issues among laboratory animals.
Quality Assurance of Operations
CSL Behring
Kankakee, IL
03.2020 - 09.2020
- Root cause analysis, batch record review, and ensuring the completion and accuracy of investigations.
- Promoted a culture of accountability within the department by setting clear expectations for performance and holding team members responsible for achieving results.
- Provided training for new hires, fostering a supportive learning environment conducive to success in their roles.
Veterinary Assistant
Oak Hill Animal Clinic
Crown Point, IN
03.2019 - 03.2020
- Maintains files and records of all patients to ensure the dates and information are correct.
- Assists in vaccine/ medication administration, proper restraint, blood draws, radiographs, and surgical patient preparation.
- Conducts laboratory tests such as gram stains, bloodwork, and immunoassay titer tests.
- Prepare for surgeries, assist in surgeries, post-surgery clean-up, and sterilization of equipment/ tools.
Professional Dog Bather
PetSmart
Schererville, IN
06.2017 - 06.2019
- Utilized specialized grooming tools to enhance bathing efficiency and effectiveness.
- Implemented best practices for pet handling, resulting in reduced stress during baths.
- Collaborated with team members to streamline workflow and improve service delivery.
Manager
Aurelio’s
Crown Point, IN
05.2016 - 05.2017
- Oversee a crew of approximately 7-12 people and keep them on task
- Deal with and properly handle upset customers
- Trained new employees and would create cheat-sheets to help them learn a position quicker
Carry-out Girl
Aurelio's Pizza Of Crown Point
Crown Point, IN
09.2014 - 05.2016
- Answer phone calls and help customers take down their order
- Make the appetizers, pastas, salads, and sandwiches
- Cleaning of designated areas
Education
Bachelor of Science - Business Administration
Capella University
Minneapolis, MN04-2027
Bachelor in Science - Biology, Minor in Chemistry
Purdue University Northwest, College of Biological Sciences
Hammond, IN05-2019
Skills
- Lean Six Sigma problem-solving
- Stakeholder Communication and Collaboration
- Leadership and Team Guidance
- High-Complexity problem-solving
- Change management support
- Data analysis and process improvement
Certification
- Certified Yellow Belt, Lean Six Sigma - November 2025
Note Worthy
Recognized as a 5-star Transformational Employee for two consecutive years at CSL Behring
Called into two audits to defend investigation work, both completed with no auditor comments or findings at CSL Behring
Received Employee of the Quarter recognition at Charles River Laboratories
Advanced to Lead Technician in the zebrafish facility and given responsibility for supporting operations in a new facility
Employee of the month multiple times at PetSmart
Promoted to manager at Aurelio's for Hard work and dedication
Timeline
Investigation Owner
CSL Behring
04.2022 - Current
Animal Care Technician
Charles River Laboratories
09.2020 - 03.2022
Quality Assurance of Operations
CSL Behring
03.2020 - 09.2020
Veterinary Assistant
Oak Hill Animal Clinic
03.2019 - 03.2020
Professional Dog Bather
PetSmart
06.2017 - 06.2019
Manager
Aurelio’s
05.2016 - 05.2017
Carry-out Girl
Aurelio's Pizza Of Crown Point
09.2014 - 05.2016
Bachelor in Science - Biology, Minor in Chemistry
Purdue University Northwest, College of Biological Sciences
Bachelor of Science - Business Administration
Capella University