Jean Viirre MT ASCP

***** ******** **** *********, ******** 60030

847-***-**** (H) 847-***-**** (C) acd9cq@r.postjobfree.com

SUMMARY

An energetic, creative, and results-motivated professional with extensive

and diverse Medical Device / healthcare sector experience. Able to adapt

to a rapidly changing FDA / ISO regulated work environment. Solid

communication and leadership skills in a team setting and individual

contributor. A leader with a proven track record with training personnel.

Ensures customer satisfaction by implementing thoughtful, technical, and

analytical ideas to obtain innovative solutions. A strong work ethic with

strengths in quality, project management, CAPA, product improvements,

change control, and in the laboratory environment. Technical writing with

attention to details.

EXPERIENCE

Baxter Healthcare, Round Lake, Illinois

Quality Product Surveillance Coordinator 2014- Current

Responsible for opening and managing complaint files and investigations.

Dealt with patients, customers, and health care professionals via

telephone or mail to ensure accurate information is obtained to

investigate complaints on renal peritoneal dialysis instruments, ancillary

components, and solutions. Responsible for initiating investigation plans

to address complaints. Determine if a medical assessment is needed on a

complaint an if aMDR is necessary. Assure complaints are logged accurately

and closed in a reasonable and timely manner.

ABBOTT LABORATORIES, Abbott Park, Illinois

Technical Shared Services - Project Manager, 2009-2013

Served as the lead project manager for discontinuation of products and

platforms. Streamlined numerous processes. Successfully managed multiple

cross-functional teams to achieve timelines and goals. Authored and

coordinated design plans, change control documents, and ePAS packages.

Executed risk management activities and CAPA documentation. Determined

obsolete parts and documents. Created new types of processes. Trained co-

workers and global sites on new procedures and processes. Eliminated

hundreds of thousand of dollars of obsolete inventory. Removed over 10,000

reagents, parts, and commodities. Eliminated over 15,000 documents from

Document Management Systems' database. Worked with third-party

manufacturing site.

Business Excellence - Technical Support/Validation Scientist, 2008-2009

Authored characterization and validation protocols. Analyzed and verified

data. Developed and implemented new test procedure incorporating a

unique way to interface instruments with software to quantify fluorescence

samples, resulting in cost savings of over $300,000. Co-developed new test

method procedure that automated the procedure and produced cost savings.

Transferred 14 assays to European manufacturing sites.

Therapeutic Drug Monitoring Area - Technical Support Scientist, 2006-2008

Maintained product availability, completed investigations, and addressed

manufacturing and customer support issues. Established protocols,

performed laboratory testing, and analyzed data. Interacted with all

levels of medical and scientific professionals. Optimized instruments and

commodities to improve assay performance. Performed testing,

troubleshooting, and conducted training at numerous customer sites. Lab

manager that coordinated lab testing. In charge of numerous projects

related to customer issues and product improvements. Composed change

requests and created new documents. Addressed, performed, documented, and

closed customer complaints and investigations. Worked with IRB protocols

and clinical samples.

Benchtop Analytical Quality - Quality Testing Professional, 2004-2006

Certified as a quality technician. Promoted to lane leader for Benchtop

Quality Lab. Supervised three technicians. Tested using multiple types of

diagnostic instruments. Trained co-workers on technical challenging

testing procedures. Executed investigations and authored CAPA packages.

Responsible for performing audits and ensuring labs met GMP standards and

ISO 9000 requirements. Generated data and information for FDA audits.

Transplant Business Team - Advance Product Specialist, 1992-2004

Primary technical product specialist for a $40 million transplant product

line. Scheduled manufacturing and testing activities for ten products.

Visited customer sites globally to successfully investigate, solve issues,

and conduct training seminars. Closed customer investigations and

complaints. Produced customer training guides for transplant assays.

Developed and implemented IMx Customer Workshop Facilitator's Guide.

Tracked all components and assay performance. Achieved qualification as a

job competency trainer. Presented data and demonstrated procedures to the

FDA. Worked alongside with regulatory on Pre-Market Approval submissions

and yearly reports.

RIA/EIA Analytical Laboratory - Quality Assurance Technician III, 1990-1992

Generated testing for cancer and PD bead product lines.

ST. THERESE HOSPITAL, Waukegan, Illinois

Chemistry Laboratory - Healthcare Professional: Registered Medical

Technologist

Executed critical laboratory testing using numerous analytical platforms.

Performed phlebotomy.

COMPUTER SKILLS

Microsoft Office Suite, Adobe Acrobat, Lotus Notes, Document Management

System, Electronic Change System, Abbott Material Management

System,Electronic Laboratory Notebook, Cognos, Isotrain, LIMS, Pilgrim,

Oracle, Outlook, Power Point

EDUCATION

BS in Medical Technology from Mundelein / Loyola University;Chicago,

Illinois

Certified Medical Technologist by the American Society of Clinical

Pathologists

CAREER Highlights

3 Silver Awards in 2012, ADD Science Award for Product and Process

Improvements in 2006, Vice President Award for Validation Effort in 2000,

Chairman's Award in 1997, and Therapy Monitoring Team Award in 1996.

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