P. 1
Quality Auditor or Quality Assurance Manager or Quality Systems

Quality Auditor or Quality Assurance Manager or Quality Systems

|Views: 12|Likes:
Published by api-77222618
Quality Auditor, Quality Assurance Manager, Quality Systems Analyst, Analyst, Compliance Manager, Quality Compliance, Regulatory Affairs, Quality Assurance Specialist, Quality Systems Specialist, Pharmacovigilence, Quality Auditing, Raw Material Manager,
Quality Auditor, Quality Assurance Manager, Quality Systems Analyst, Analyst, Compliance Manager, Quality Compliance, Regulatory Affairs, Quality Assurance Specialist, Quality Systems Specialist, Pharmacovigilence, Quality Auditing, Raw Material Manager,

More info:

Published by: api-77222618 on May 26, 2011
Copyright:Attribution Non-commercial

Availability:

Read on Scribd mobile: iPhone, iPad and Android.
download as TXT, PDF, TXT or read online from Scribd
See more
See less

06/17/2014

pdf

text

original

Cameron E. Jones 2201 W. 93rd Apt 202 Cleveland, OH 44102 248.227.

1503 EXPERIENCE August 2009-Present Quality Systems Specialist, Boehringer-Ingelheim - Ben Venue Laboratories, Bedford, OH Technical Writing and Investigation Qualification: * Perform root cause analysis to determine corrective actions in response to lab oratory and manufacturing related deviations. * Generate metrics to analyze historical product data, track improvements to sit e processes. * Review standard operating procedures (SOPs) prior to final approval or impleme ntation. * Author protocols as analysis tools for determining the root cause of an invest igation. * Submit process improvements through the change control process. * Support Annual Product Review data metrics. * Identify and address deviation trends. * Investigate product complaints. April 2006-Aug 2009 Quality Assurance Specialist, Emergent BioSolutions - Biodefense Operations, Lansing, MI Regulatory Qualification: * Perform root cause analysis to determine corrective actions in response to man ufacturing related deviations. * Review BioThrax - Anthrax Vaccine Absorbed Master Production Records and Qual ity Control Data. * Review documented maintenance activities for compliance. * Inspect production activities throughout the facility. * Disposition raw material and final product lots. * Author technical writing documents - i.e. (SOPs) * Train incoming QA staff members. Manufacturing Associate III, Emergent BioSolutions - Biodefense Operations, Lansing, MI Aseptic Manufacturing Qualification: * Perform environmental monitoring of the production facility - i.e. (RODAC and HIAC testing). * Execute fermentation of Bacillus Anthracis in Bioreactors. * Track growth and termination of Bacillus Anthracis. * Compound Media for growth of Bacillus Anthracis. * Aseptically sample and process Bacillus Anthracis. * Train new employees in production procedures. * Adhere to GMPs, GLPs, GDPs. January 2005-Nov 2005 Cytotechnology Intern, Detroit Medical Center - University Laboratories, Detroit, MI Laboratory Qualification: * CYTYC Thinprep microscopic morphology training - Marlborough, MA * Participant in the American Society for Cytotechnologists conference - Rare ca se presentation "Metastatic Renal Cell Carcinoma Reported in Patient's Liver" L as Vegas, NV * Participation in colposcopy conferences.

January 2003-Jan 2005 Satellite Laboratory Assistant II, St. Joseph Mercy Oakland Hospital, Pontiac, MI Additional Laboratory Qualification: * Aseptically collect blood samples from inpatients and outpatients. * Responsible for accurate insurance billing and registering of new patients. EDUCATION: Oakland University, Rochester, MI, Bachelor's of Science, Medical Laboratory Sci ence Rochester College, Rochester Hills, MI, A.S. General Biology ADDITIONAL SKILLS: Microsoft Visio, Word, Excel, Access, PowerPoint, Communicator, Adobe Illustrato r professional, TrackWise, SAP, Adobe Photoshop, Illustrator, HTML coding/buildi ng, Local SharePoint Administration. www.cameronjones.org

You're Reading a Free Preview

Download
scribd
/*********** DO NOT ALTER ANYTHING BELOW THIS LINE ! ************/ var s_code=s.t();if(s_code)document.write(s_code)//-->