Juul Labs
Senior Quality Engineer
Porex Filtration Group Global Life Sciences May 2016 - Jul 2017
Designated Quality Assurance Engineer 5 and Sme Cgmp Facilitator
Operational Quality Systems Improve Experts Sme Consultant on Site Aug 2015 - May 2016
Sme Consultant
Endeavor Belcan Engineering/Nne/Sme Qa Consulting J&J/Dsm/Patheon and Virbac Company May 2014 - Aug 2015
Sme Qa Consulting
Immucor, Inc. Apr 2013 - Jul 2013
Cgmp and Cglp Sme Consultant
Education:
Shawnee State University Dec 1997
Bachelors, Bachelor of Science
Shawnee State University 1995 - 1997
Indiana University Northwest
Skills:
Pharmaceuticals Cgmp Gmp Validation Aseptic Processing Compliance Biopharmaceuticals Dea Quality Auditing Lims Inprocess/Finish Material Regulatory Affairs Generics Regulatory Requirements Capa Fda Sop Medical Devices Change Control Technology Transfer Glp Process Validation Regulatory Strategy Gxp Clinical Trials 21 Cfr Part 11 Gcp Biotechnology Quality Systems Iso 13485 Cleaning Validation Lyophilization Hplc Validations Life Sciences Certified Six Sigma Green Belt Certified Lean Asq Member Product Sampling Raw Materials Packaging Start Ups Sop Development Large Bulk Manufacturing Project Management Cultivated Quality Circle Teams To Resolve Complex Issues Certified In Aseptic/Ts Gowning Review and Edit Control Documents Blood Plasma/Blood Pathogens/And Reagents Apis and Formulations
Certifications:
Six Sigma Green Belt Certified/ Lean Certified/ Aseptic Certified/Several Years Experience In Qms Iso 9000/13485
Abbott Laboratory/Hospira Rocky Mount, NC May 2003 to May 2011 Supervisor in EngineeringOlsten Technical Staffing/Bayer Pharmaceutical Clayton, NC Jun 1999 to Mar 2002 Environmental Monitoring Technician/Micro Lab TechnicianSherwin Williams Company Chapel Hill, NC Sep 1998 to Jun 1999 Assistant Manager
Education:
Shawnee State University Portsmouth, OH Dec 1997 Bachelors of Science in Natural Science
Grace Briggs (1975-1979), Michael Koukos (1978-1982), Sean Sontag (1974-1978), Frank Couzens (1938-1942), Joe Jospeh (1996-2000), Sarah Knup (1994-1998)