Quality Assurance Control
Resume:
Maria Burdel
Park Ridge NJ *****
*******@*********.***
Experience
Antech Diagnostics Lake Success, NY
Manager, Quality Assurance and Quality Control
• Monitor 30 Laboratories in all aspects of QA/QC (Chemistry, Hematology, Serology, Coagulation).
• Perform audits of 20 Laboratories against the Companies Quality Management System (QMS).
• Initiate, define audit objectives, review documents and prepare plan for onsite audit activity.
• Execute audit following the companies quality system (SOP)
• Report audit results to senior management.
• Conduct follow-up audits.
• Assist in implementation of ISO/IEC 17025 Standards to achieve ISO certification.
• Work with Lab Mangers and staff to implement new procedures, update and changes.
• Monitor and support Quality improvements
• Provide staff training and technical assistance with equipment and methods (includes observing testing
methods to ensure compliance with SOP)
• Work with Lab Managers and supervisors to ensure compliance with SOP methods and techniques to
assure lab precision and accuracy.
• Prepare Validation Reports and create/update SOP’s.
Instrumentation Laboratories Orangeburg, NY
1996 to 2009
Scientist for Quality Assurance and Product Support
Review incoming complaints from Beckman Coulter and foreign countries, which are in the SAP database.
•
Analyze complaints, if confirmed assign corrective action and perform root cause analysis within a team
•
environment.
Collaborate with design teams.
•
Follow through with Beckman Coulter or affiliates regarding complaints and gathering additional information.
•
Investigate products in collaboration with R&D and manufacturing.
•
Review complaint files for reportability to the FDA.
•
Train and supervise support staff.
•
Continuous training in medical device reporting.
•
Problem solving through team approach and multi departments.
•
Coordinate and preside over meetings to discuss complaint issues.
•
Prepare and maintain complaint trending reports using pareto charts.
•
Review and discuss complaints with company affiliates, manufacturing, management and
•
R&D if reporting is needed to the FDA per 21 CFR part 820 and ISO9001.
Coordinate Stabilities for all Product Lines.
•
Prepare Validation Protocols and Reports for Dating Extensions of Products and Raw
•
Material changes when requested.
• Applied knowledge of GMP, ISO 9001:2000, GLP and 21CFR Part 820.
Maria Burdel
Page 2 of 2
Prospect Medical Offices Ridgewood,NJ
1995 to 1996
Medical Laboratory Technician
• Performed hemograms on Coulter MD including differentials,
Urinalyses, venipuncture and finger sticks.
• Maintain records of results and quality control.
Teledyne Brown Engineering Westwood, NJ
1988 to 1994
Technical Assistant and Assistant Q.A. Manager
• Provided information and technical support to customers and representatives about Tritium and Radon
testing.
• Tested samples for Tritium and Radon radioactivity.
• Audit responsibility for State and Customers.
• Trained support staff.
• Completed testing reports.
Senior Laboratory Technician
• Extracted low level radioactive nuclides such as Sr 89/90, Fe 55 from water resins and air samples.
• Methods used for extractions completed by columns and wet chemistry.
Kreiskrankenhaus (Hospital) Neu-Ulm, Germany
Medical Laboratory Technologist
• Conducted Hemogramm, substratum determinations, flame photometry, overall blood group serology
including cross matching.
• Performed blood gas analysis, veni, ascite and pleura puncture, electrophoresis and chromatography test.
• Maintained rigorous and precise research methods, records of results, and Quality Control.
Education
present
• Currently pursuing ASQ,9 Certified Quality Auditor Certification (CQA)
Technical Academy of Natural Sciences Isny, Germany
Medical Laboratory Technologist
• Degree conferred by University of Tuebingen
• Medical Laboratory Technologist Certification.
Specialized Skills
• Proficient in Microsoft Office (Word, Excel, Power Point), Lotus Notes, Outlook and SAP.
• Bilingual, Fluent in German.
Contact this candidate