Jeanette Ariel Kotonias
Bedford,VA
Summary
Validation specialist with 18 years of experience in cGMP environments, specializing in Stage II Process Validation and Stage III Continued Process Verification. Expertise in statistical process control analysis and proficient in software tools such as JMP and CPV generative applications. Skilled in Microsoft applications, SAP, Wisdom, and QualityDocs, ensuring high-quality results. Detail-oriented professional capable of independent work under pressure.
Overview
17
17
years of professional experience
Work History
Senior Specialist, Engineering
MERCK & CO, INC.
Elkton, USA
07.2019 - Current
- Develop and implement continued process verification plans and reports.
- Conduct technical assessments to support statistical process control initiatives.
- Design and manage CAPA requirements to ensure compliance and quality improvement.
- Create and revise Standard Operating Procedures, forms, and related documentation.
- Provided guidance on statistical process control applications.
- Analyze data trends to inform and optimize process performance.
- Discuss continued process verification (stage III validation) documents with auditors and inspectors during on-site inspections and audits.
Validation Specialist
TEVA PHARMACEUTICALS
Forest, USA
06.2008 - 07.2019
- Developed and executed validation protocols for new and existing products.
- Conducted validation studies to ensure compliance with manufacturing processes.
- Reviewed and approved validation documentation for accuracy and thoroughness.
- Monitored ongoing validation activities to uphold quality standards.
- Assisted in audits by providing essential validation records and reports.
- Generated packaging validation protocols and reports, ensuring product integrity.
- Analyzed data using statistical process control techniques for quality assurance.
- Designed, managed, and fulfilled CAPA requirements to enhance operational efficiency.
Education
Bachelor of Science - Physics
Sweet Briar College
Amherst05-2006
Skills
- Process verification and validation
- Statistical analysis and interpretation
- Technical assessments
- Attention to detail
- Critical thinking skills
- Quantitative analysis
- Regulatory compliance
References
References available upon request.
Timeline
Senior Specialist, Engineering
MERCK & CO, INC.
07.2019 - Current
Validation Specialist
TEVA PHARMACEUTICALS
06.2008 - 07.2019
Bachelor of Science - Physics
Sweet Briar College
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