Timothy Stefanizzi
Waynesburg,USA
Summary
Detail-oriented Chemist with 16 years of experience working in quality systems within the pharmaceutical industry. Experienced in analytical chemistry, quality assurance, quality control, manufacturing, method development/validation, document control, and cGMPs in a highly regulated and fast-paced industry.
Overview
16
16
years of professional experience
Work History
Quality Assurance Specialist II
SOFIE Biosciences
Morgantown, WV
04.2022 - Current
- Oversaw Quality Management Systems at SOFIE Radiopharmacy for manufacturing and distributing PET drug products under 21 CFR Part 211 and 212, ensuring compliance and quality standards.
- Authored, reviewed, and approved quality control and manufacturing records.
- Served as subject matter expert in laboratory operations, including HPLC, GC, TLC, etc.
- Collaborated with Corporate and Facility Operations teams to implement continuous improvement projects, enhancing operational effectiveness.
- Authored, reviewed, approved, and implemented procedures and specifications.
- Conducted audits to monitor compliance with established procedures.
- Coordinated with management of third-party business partners and contractors to resolve issues and meet project objectives.
- Analyzed data against established specifications and to identify trends.
- Initiated, investigated, and completed Deviation, Complaint, Out of Specification, Atypical Yield, and Change Control Reports.
- Performed root cause analysis and implemented effective corrective/preventative actions.
Manager Quality Control
Viatris (Formerly Mylan Pharmaceuticals)
Morgantown, WV
07.2010 - 07.2021
- Managed daily laboratory operations and laboratory employees across multiple functional areas within the Quality Control department.
- Coordinated Quality Control investigations, ensuring timely capture, documentation, and resolution.
- Performed root cause analysis and implemented corrective/preventative actions.
- Communicated effectively with other departments to resolve issues and improve efficiency.
- Authored and approved key documentation, including SOPs, protocols, work instructions, and analytical investigations.
- Participated in cGMP audits performed by domestic and international regulatory agencies.
- Developed and implemented equipment cleaning validation and verification testing programs.
Senior Chemist/Complex Products Team Lead
Viatris (Formerly Mylan Pharmaceuticals)
Morgantown, WV
07.2013 - 08.2015
- Led high priority projects analyzing pharmaceutical products to ensure compliance and quality standards.
- Coordinated testing schedules for team members to meet project deadlines and maintain workflow efficiency.
- Mentored and served as a resource for less experienced analysts.
- Supervised laboratory operations on afternoon shift in absence of an Associate Manager.
- Conducted investigations of aberrant results and compiled written reports to document findings and recommend corrective actions.
Analytical Chemist
Viatris (Formerly Mylan Pharmaceuticals)
Morgantown, WV
07.2010 - 07.2013
- Executed testing of raw materials, intermediates, and finished pharmaceuticals using High Pressure Liquid Chromatography (HPLC) with UV-Vis, PDA, Fluorescence, Refractive Index, Conductivity, and Electrochemical detection to ensure product quality and compliance.
- Conducted maintenance, review, and audit of logbooks and laboratory documentation in adherence to cGMP standards, ensuring regulatory compliance and data integrity.
- Diagnosed and repaired laboratory instruments to maintain optimal functionality and accuracy in testing procedures.
Education
Bachelor of Science - Chemistry
Bethany College
Bethany, WV05-2010
Skills
- Manufacturing QC
- Quality Management Systems
- Regulatory compliance
- Analytical Chemistry
- Risk management
- Root Cause Analysis
- Corrective actions
- Change Control
- Equipment validation
- Test results analysis
- Data analysis
- Technical Writing
- Microsoft Office (Word, Excel, Access, Outlook)
- Problem Solving
- Training development
- Instrument maintenance
Timeline
Quality Assurance Specialist II
SOFIE Biosciences
04.2022 - Current
Senior Chemist/Complex Products Team Lead
Viatris (Formerly Mylan Pharmaceuticals)
07.2013 - 08.2015
Manager Quality Control
Viatris (Formerly Mylan Pharmaceuticals)
07.2010 - 07.2021
Analytical Chemist
Viatris (Formerly Mylan Pharmaceuticals)
07.2010 - 07.2013
Bachelor of Science - Chemistry
Bethany College