VRUSHANK SHAH

** ********** ***** ***** ****** NC 28752

734-***-**** acpjc5@r.postjobfree.com https://www.linkedin.com/pub/vrushank-shah/59/540/310

SKILLS & ABILITIES:

* ***** ** ******** **** experience in a cGMP regulated industry.

4 years of product knowledge related to medical devices.

Co-led and supported 4 FDA, Saudi Arabia, TUV, EU, 6 Client and 2 internal audits.

Excellent written, communication, interpersonal and problem resolution skills.

Detail and result oriented completion of tasks with ability to multi-task effectively.

Demonstrated ability to function effectively as a team player as well as working independently to achieve company’s goals.

Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, an d decision making.

Possess strong skills in Microsoft Office, Lean / Six Sigma, DMAIC, CAPA, Trackwise SPC, Minitab, Pilgrim, AutoCAD,

PFMEA and FDA Requirements.

Qualified to gown in A/B grade areas.

EDUCATION:

Southern New Hampshire University, University of Illinois at Chicago (UIC), Oakton Community College

Manchester, NH Chicago, IL (OCC),

Dual MBA in Healthcare Management and Bachelor of Science in Liberal Arts and Science, Des Plaines, IL

Healthcare Informatics, GPA(3.96/4.0) Major: Biochemistry, Minor: Computer Science Associate of Sciences

Expected Graduation: May 2016 GPA(3.83/4.0) GPA(4.0/4.0)

CERTIFICATIONS:

Six Sigma Yellow Belt by Baxter Healthcare, November 2014

Certified Quality Engineer (CQE) by American Society for Quality (ASQ), # 62544, June 2014

Lean Boot Camps by Baxter Bloomington, 2013and Baxter Cleveland, 2012

Baxter Management Essentials

PROFESSIONAL EXPERIENCES:

08/14 – Present: Quality Supervisor (Quality Development Program – Year 3)

Baxter Healthcare, NorthCove, NC

Oversee a team of Quality personnel and determine adequacy of quality and compliance aspects of various quality operations.

Participate in remediation and continuous improvement of Particulate Matter (PM) project in the role of contributor,

coordinator or lead.

Participate and lead corrective and preventive actions for the temperature and humidity/ Kiefel CAPA.

Draft, review, analyze and revise written SOPs, Protocols, Trackwise events and CAPA investigations in order to meet

Corporate, Divisional, Plant, Regulatory Requirements, etc.

Monitor and trend production metrics, route tasks, and alert upper management about situations that can affect production

timeliness.

Complete initial threshold lot analysis based on complaint data for each problem code and its associated problem codes per

Baxter’s Protocol for Field Corrective Action (FCA) project.

Complete Risk Assessment for distributed products in Baxter’s form for FCA project.

07/13 – 08/14: Quality Project Co-lead (Quality Development Program – Year 2)

Baxter Healthcare, Cleveland, MS

Co-Led the Bioscience Bio Surgery products (Approx. 10) transfer project from Irvine, CA to Cleveland, MS.

Led cross-functional problem solving and process improvement teams.

Managed project schedules to delegate activities between different Baxter Cleveland departments and Baxter plants

(Roundlake, IL, Irvine, Hayward, and Thousand Oaks CA)

Assisted with and prepared risk management documentations in support of new and existing product lines.

Monitored and reported project costs including capital and cross-functional expenses.

Drew room layouts for 43 clean rooms of the plant via AutoCAD for the EMPQ project.

06/12 – 07/13: Quality Associate (Quality Development Program – Year 1)

BioPharma Solutions, Baxter Healthcare, Bloomington, IN

Participated and supported as a Guest Auditor in various Regulatory Agencies, Corporate Clients and Internal Audits.

Led and assisted on Lean Management, Visual Control and Daily Accountability projects.

Responded as a quality associate to the quality issues that occurred during the production.

Supported the Complaint’s Department in reduction of number of complaints and their continuous improvements.

Performed re-evaluations of Baxter’s suppliers using performance data (SCARs, internal audits & procedural requirements).

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07/11 – 05/12: Global Product Surveillance Analyst, Service Record Remediation

Baxter Healthcare, RoundLake, IL

Performed timely retrospective review of assigned Medical Device Service Records to identify complaints from ancillary

service activities.

Initiated complaints from this review and assigned as reported problem codes.

Determined FDA reportability of complaints initiated from above review & assigned FDA MDR codes to those complaints.

Escalated issues and potential solutions as appropriate to management team

Collected necessary complaint information to determine if it can be reported and submitted associated MedWatch reports

within 30 days as per regulations.

04/08 - 08/10: Insurance Specialist, Pathology Lab, University of Illinois Medical Center, UIC, IL

Assisted in entering insurance information of the patients.

Communicated with the insurance companies and patients to find out insurance details.

Followed correct procedure to file paper work and bill patients and insurance companies.

RESEARCH EXPERIENCES:

08/10 - 05/11, Student Researcher, Biochemistry and Advanced Synthetic Laboratory Class, Chemistry Department, UIC, IL

Utilized techniques such as melting point determination, infrared spectroscopy, nuclear magnetic resonance spectroscopy,

synthesis of various organic molecules within biology, medicine and pharmacology.

Performed gel filtration chromatography, ion filtration chromatography, PCR, gel electrophoresis, agar plate analysis and

other biological techniques to find more information about the DNA.

Researched and developed experimental procedures for the reduction of conjugated alkenes on solid support resins toward

the total synthesis of two natural products: zinger one and raspberry ketone. This was part of the CASPIE project and the

resultant molecule was sent to Bergstrom group at Purdue University.

04/08 - 12/09, Pharmacy Technician, Pharmacy Dept, UIC Medical Center, UIC, IL

Entered the prescription orders on computer, filled and delivered them.

Checked the Omni cell, Medical cart and other pharmacy related devices and replenished them with appropriate medications.

Shadowed the clinical pharmacist and observed their specific methods of treatments.

05/06 - 12/07, Member, Research Team, OCC, Des Plaines, IL

Performed several experiments under the supervision of an organic chemistry professor to find an appropriate medicine for

Alzheimer’s disease.

Researched and observed the effects of “Avastin” on macular degeneration under the supervision of a team that contained an

ophthalmologist, physicians, pharmacists and an organic professor from OCC.

Maintained record of long term patients via computerized systems.

LEADERSHIP EXPERIENCES:

04/09 - 01/11, Orientation Leader, Office of Student Development Services, UIC, IL

Led groups of 15 and more transfer & freshmen students during their one and/or two day of orientation programs.

01/09 - 03/10, Assembly Member, Undergraduate Student Government (USG), UIC, IL

Led ASGA (American Student Government Association) conference at UIC, which was attended by 25 0 students

from 30 different Midwest and west coast universities.

05/06 - 01/08, President, Board of Student Affairs (BSA), OCC, Des Plaines, IL

Led and managed an assembly of 28 talented student leaders.

Planned and implemented annual banquet for more than 800 students, Oakton administrators and employees.

AWARDS & HONORS:

Recipient, Magna cum laude, UIC, 2011

Recipient, Chancellor’s Student Service and Leadership Award, UIC, 2010,09,08

Recipient, Orientation Leader of the Year Award, UIC, 2010, 09

Recipient, National Dean’s List, OCC, Spring & Fall 2008,07,06

Recipient, President’s Scholar, OCC, 2008,07,06

Featured in Pioneer Newspaper for the Illinois Faculty Association Scholarship, 2007

Featured in Outlook Magazine for the successful International Student at Oakton, 2007

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Featured in Daily Herald’s Northwest Newspaper on the front page, for being one of the successful international students

among all northwest community colleges, 2007

Featured in Chicago Tribune Newspaper for contribution to DNA research, 2006

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