Stephanie Fitzgerald
QC Standards & Stability Manager at Corden Pharma - A Full-Service CDMO
- Role
- Qc Standards & Stability Manager at Corden Pharma - A Full-Service CDMO
- Location
- Denver, CO, US
- LinkedIn followers
- 500 followers
About Stephanie Fitzgerald
Transformational Sr. Quality & Operations Manager with in-depth experience driving business and quality results in complex, fast-paced environments through Lean Six Sigma process improvement strategies, collaboration, and communication. Successfully build, develop, and lead high performing teams through visionary and transformational leadership styles. Passionate about unlocking talent and establishing mission driven quality management systems for employees and businesses. Operations Sr. Manager/Quality ManagerEmail: S••••••••@gmail.comWith a solid foundation in Operations Management and a track record of enhancing product safety and risk assessment, my role as Quality Control Manager at Charlotte\'s Web has been pivotal in driving compliance and quality across our operations. Our team\'s dedication to excellence led to significant cost savings through strategic decisions, such as reducing reliance on third-party \"High Priority\" lab testing, which saved the company $1.4 million over the year.My expertise in analytical chemistry and process improvement has been instrumental in establishing and managing a formal ICH Stability program and a robust Sample Management system. In collaboration with cross-functional teams, I’ve implemented quality control processes that not only ensure product quality but also align with industry regulations, demonstrating my commitment to upholding the highest standards in this field.CORE COMPETENCIES Team Leadership Robust Quality Systems Operations Management Lean/Six Sigma Regulatory Compliance: USDA/FDA/OSHA Logistics Budget/KPIs Communication and Collaboration Project Management Conflict ResolutionACCOMPLISHMENTS Implemented storage of all stability samples in-house. Impact:$330k savings over next yr. Streamlined all 3rd party testing to 1 lab. Impact:~$200k/yr savings in testing and shipping. Implemented Cross Dock to save $270K in associated fuel and wage costs in a single quarter. Increased JIT, trucks on the first class galley by 32%. Decreased monthly delays by 97%.Contact me at S••••••••@gmail.com for any Sr. Quality/Operations Management job opportunities.
Experience
Qc Standards & Stability Manager
Corden Pharma - A Full-Service CDMO
Apr 2026 — Present · Boulder, CO, US
By harnessing the collective strength across our globally-integrated network of cGMP manufacturing facilities and expert teams, we provide complex modalities such as Peptides, Lipids, Oligonucleotides, Injectables, and Small Molecules including Highly Potent – all supported by our technology platforms.
Education
Regis University
Bachelor's degree
Skills
- Lean Manufacturing
- Continuous Improvement
- Visual Management
- Standard Work
- Kanban
- Plant Management
- 5s
- Tpm
- Transportation
- Quality System
- Logistics
- Dmaic
- Operational Excellence
- Leadership
- Manufacturing Operations Management
- Supply Chain Management
- Strategic Sourcing
- Cross-Functional Team Leadership
- Lean Transformation
- Supplier Quality
- Purchasing
- Value Stream Mapping
- A3
- Process Improvement
- Oee
- Operations Management
- Supply Chain
- Materials Management
- Food Processing
- Supply Chain Optimization
- Quality Management
- Food Safety
- Logistics Management
- Kaizen
- Haccp
- Smed
- Toyota Production System
- Production Planning
- Lean Operations
- Spc
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