Peter Olenoski

Quality Assurance Site Lead @Thermo Fisher Scientific

New Haven, CT, US
EMAILS
p••••••••@thermofisher.com
MOBILE NUMBERS
+12•••••••29

Signup · Get unlimited contacts

WORK HISTORY

Apr 2018 — Present

Quality Assurance Site Lead @Thermo Fisher Scientific

View department →

As the Clinical Next-Generation Sequencing Division Management Representative and Quality Assurance site lead for Guilford, CT; provide direction and continuous improvement to sustain a robust ISO 13485 Quality Management System in meeting compliance of regulated processes related to the design, development, transfer activities of Class I, II, medical devices and In Vitro Diagnostics to ensure an “inspection ready” state is maintained across all regulated activities for site Regulatory…

EDUCATION

1983 — 1988

Central Connecticut State University

Mathematics and Statistics

1983 — 1988

Central Connecticut State University

Bachelor's degree, Computer Science

SKILLS

Medical DevicesChange ControlU.s. Title 21 Cfr Part 11 RegulationBiopharmaceuticalsComputer System ValidationValidationHplc21 CfrDrug SafetyGampDrug DevelopmentGxp21 Cfr Part 11PharmacovigilanceStandard Operating Procedure (Sop)Regulatory AffairsIso 13485Pharmaceutical IndustryCleaning ValidationSoftware DocumentationQuality ManagementU.s. Food and Drug Administration (Fda)SopSdlcRegulatory SubmissionsIndBiotechnologyClinical DevelopmentQuality SystemFdaGmpCapaRegulatory RequirementsGlpGcpAnalytical ChemistryQuality ControlPharmaceuticsQuality AssuranceLims

ABOUT PETER OLENOSKI

As a Quality Management professional (Medical Device, Pharmaceutical/Biotech, Healthcare,…

This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.

Peter Olenoski — Email, Phone Number & Contact Info | Unifers