Jeffrey Nikoleyczik
Senior Quality Assurance Specialist @Thermo Fisher Scientific
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WORK HISTORY
Senior Quality Assurance Specialist @Thermo Fisher Scientific
US
Perform Clinical and Commercialized Batch Record Review and analyzes all in-process specifications, material inputs, equipment components and environmental monitoring data to ensure all internal quality standards, regulatory quality standards and client requirements are met- Release of Clinical and Commercialized Batches- Communicates with internal partners and external clients to ensure customer service needs are met- Good Manufacturing Practices Documentation and Data Integrity Subject Matter Expert- Review and Approval Internal and Client facing Deviations and assess quality impact to product and processes- Member of the Allentown Site Quality Council, CAPA Effectiveness Review Board and Deviation Assessment Group- Perform internal and external audits to ensure Good Clinical Practices(GCP) are being maintained
EDUCATION
East Stroudsburg University of Pennsylvania
B.S., Biology
East Stroudsburg University of Pennsylvania
M.S., Biology
SKILLS
ABOUT JEFFREY NIKOLEYCZIK
I have 19years of experience in the pharmaceutical industry, all of which have been in the vaccine and biologics cGMP manufacturing environment. I have 10 years of Quality experience and 9 years of management experience, holding many positions in the quality and operational areas, each with increasing responsibility and scope. During my extensive experience in the quality assurance environment, I was heavily involved in the quality aspects of many facets of the business including: qualification of new and existing equipment, Master Batch record design and review, cGMP Batch Record review, batch release, SOP review and approvals, Annual Product Reviews, Quality Risk Assessments and Change RequestsCourses and Certifications:Merck Qualified AuditorGlobal Vaccine Academy Learning Series: Right the First Time Empowering Documentation Success Contamination Control 101Lean Six Sigma Yellow Belt
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