Crystal Simon
Park Forest,IL
Summary
Dynamic Quality Manager with a proven track record at Aquestive Therapeutics, enhancing batch release metrics by 35% through effective project management and root cause analysis. Skilled in FDA audit preparation and team training, I drive continuous improvement initiatives to elevate quality standards and operational efficiency.
Overview
20
20
years of professional experience
Work History
Quality Manager
Peopleworks IL, Inc
Matteson, IL
08.2025 - 11.2025
- Implemented the Quality training program to support the hiring of new Quality Inspectors.
- Reduced battery defects by 20% within 45 days.
- Developed Quality procedures to support the Incoming, Line/Process and Outgoing Quality functions.
Quality Control Manager
Aquestive Therapeutics
Portage, IN
11.2024 - 06.2025
- Supported successful FDA and TGA audits in January 2025 and February 2025 respectively.
- Participated on the root cause task force which included identifying the root cause of an emerging atypical stability trend that had the potential to lead a product recall.
- Improved batch release metrics by 35% to support on time release of manufactured batches.
- Reduced laboratory investigations by 20% with the use of root cause analysis tools.
Quality Assurance Manager
GEA Farm Technologies
Romeoville, IL
02.2021 - 11.2024
- Provided Quality oversight at the GEA Romeoville site, as well as support GEA Fresno and Roswell sites from a Quality standpoint.
- Created new procedures for product label inspection, product recall process, and batch/manufacturing inspection.
- Reduced the number of stability investigations from 30% in 2021 to 6% in 2022.
- Successfully hosted ISO 9001:2015 recertification audit in April 2022 and initial certification audits for ISO 14001:2015 and ISO 45001:2018 certifications in July 2022.
Technology Transfer Lead
Fresenius Kabi USA
Melrose Park, IL
07.2019 - 02.2021
- Managed validation project executions for new product transfers, site transfers and cleaning verifications/qualifications.
- Led the site transfer of Dexamethasone Sodium Phosphate Injection (potential treatment for COVID-19) as the study director.
- Supported the bulk hold extension study for Levothyroxine Sodium Injection RTU and supporting the cleaning requalification of Lyophilizers RL-1 through RL-5 for Belinostat for Injection as the study director.
Senior Chemist
Aquestive Therapeutics
Portage, IN
07.2018 - 07.2019
- Performed HPLC, Karl Fischer, and Dissolution QC test methods to support the product launches of Sympazan, Diazepam, and Vitafol.
- Proficient with electronic Quality Management System software MasterControl.
Production Supervisor II
CSL Behring
Kankakee, IL
10.2017 - 06.2018
- Supervised the activities of 13 production operators in Building 21 (API) to assure safe, timely, efficient manufacture of Zemaira in accordance with department policies and procedures.
- Knowledgeable in plasma protein purification via extraction, plate and frame filtration, column chromatography (IEC and HIC), ultrafiltration/diafiltration, liquid heat pasteurization, planova filtration and sterile filtration techniques.
- Supported the validation of PAS-X Werum MES by initiating, submitting and reviewing batch records electronically.
Development Scientist
CSL Behring
Kankakee, IL
09.2016 - 10.2017
- Managed method development and method validation initiatives for the Chemistry Raw Materials group.
- Performed USP, EP, ACS and in-house raw materials assays, including wet chemistry methods, Karl Fischer, FTIR, GC, and HPLC.
Stability Scientist
CSL Behring
Kankakee, IL
11.2013 - 09.2016
- Authored stability protocols and stability reports to support Regulatory submissions and Annual Product Quality Review.
- Reduced stability inventory discrepancies by 40%, implemented manual biannual stability inventory counts.
- Provided stability support for the launch of new product, AlbuRx and the batch size increase of existing product, Zemaira by authoring stability protocols, completing interim and final stability reports to support Regulatory submissions.
Lead Chemist
CSL Behring
Kankakee, IL
10.2012 - 10.2013
- Led a group of 5 analysts on third shift for the Chemistry In Process group.
- Supported production by completing QC product testing on in process and finished product samples utilizing pH meters, auto-titrators, GC, ISE, spectrophotometers, HPLC, LAL endotoxin testing, microplate readers, flame photometer, micro/macro Kjeldahl testing, AA, and Leco Nitrogen testing.
Senior Chemist
Celgene Corporation
Melrose Park, IL
08.2008 - 01.2012
- Responsible for leading a group of 3 chemists on third shift.
- Reduced invalid laboratory tests by 30% with the implementation of corrective and preventative actions for repeat occurrences.
- Audited laboratory notebooks, logbooks and laboratory areas on a monthly basis.
- Supported the Phoenix Arizona site transfer of Abraxane by completing the Abraxane impurities HPLC finished product test method and GC residual solvents finished product test method.
QC Analyst II
CSL Behring
Kankakee, IL
07.2006 - 08.2008
- Performed quality control testing for the Chemistry Department on in-process, stability, and finished.
- Supported the instrument validation of the CE Elantech for Nitrogen Analysis by executing the validation protocol.
Associate Scientist
CSL Behring
Kankakee, IL
01.2006 - 06.2006
- Performed research pilot plant work for the alternative filter aid project to support the manufacturing of Zemaira.
- Completed Technical Assessments for the Technical Operations department to support manufacturing investigations.
Education
Doctor of Business Administration - Management
Argosy University
Chicago, IL02.2017
Master of Science - Analytical Chemistry
Governors State University
University Park, IL12.2007
Bachelor of Science - Biological Sciences, Minor in Chemistry
Eastern Illinois University
Charleston, IL12.2004
Skills
- Lean Six Sigma (DMAIC)
- Project Management
- Continuous Improvement Initiatives (Kaizen)
- Root Cause Analysis (5 Whys, Fishbone Diagram, FMEA)
- Problem solving
- Quality management systems
- FDA audit preparation
- Validation protocols
- Documentation management
- Internal auditing
- Team Training
- CAPA management
References
Available upon request
Timeline
Quality Manager
Peopleworks IL, Inc
08.2025 - 11.2025
Quality Control Manager
Aquestive Therapeutics
11.2024 - 06.2025
Quality Assurance Manager
GEA Farm Technologies
02.2021 - 11.2024
Technology Transfer Lead
Fresenius Kabi USA
07.2019 - 02.2021
Senior Chemist
Aquestive Therapeutics
07.2018 - 07.2019
Production Supervisor II
CSL Behring
10.2017 - 06.2018
Development Scientist
CSL Behring
09.2016 - 10.2017
Stability Scientist
CSL Behring
11.2013 - 09.2016
Lead Chemist
CSL Behring
10.2012 - 10.2013
Senior Chemist
Celgene Corporation
08.2008 - 01.2012
QC Analyst II
CSL Behring
07.2006 - 08.2008
Associate Scientist
CSL Behring
01.2006 - 06.2006
Doctor of Business Administration - Management
Argosy University
Master of Science - Analytical Chemistry
Governors State University
Bachelor of Science - Biological Sciences, Minor in Chemistry
Eastern Illinois University