Manager Quality Assurance

Vishal V. Patel

**** **** ******, *****, ** *****

Cell: 908-***-****

Email: actxnp@r.postjobfree.com

OBJECTIVE:

To obtain a challenging position in the wider Operational arena to test and increase my knowledge, and develop my foundation of techniques on an everyday basis.

SUMMARY OF QUALIFICATIONS:

William Grant and Sons, Inc., Edison, NJ April 2015 – Present Continuous Improvement Manager, Americas

-Completed Green Belt project to reduce cycle time on investigation of customer complaints. Projected efficiency savings of $138,000 dollars

-Implemented North American Work stream for Continuous Improvement, Value Engineering, and Capital Planning with expected savings of $1,600,000 in first 9 months

-Deployed first round training for Green Belt and Yellow Belt certification for Americas Operations (10 green belt, 20 yellow belt certifications)

-Completed various manufacturing projects to increase efficiency and lower costs.

-Site Co-Champion for implementation of BRC Food Safety Certification which resulted in increasing initial audit scoring from 0/100 to 84/100 in 9 months.

William Grant and Sons, Inc., Edison, NJ April 2013 – April 2015 Safety and Quality Compliance Coordinator

- Successfully developed and implemented Standard Operating Procedures, and certified the production facility to ISO 9001 and OHSAS18001 standards within 6 months of being employed, while also becoming first Lead ISO Auditor on site at our production facility and systems administrator for Q-Pulse and Weigh-Data software.

- Integral part/co-leader of Audit Team that has passed three ISO9001 and OSHAS18001 Surveillance audits with no major non-conformities.

- Became subject matter expert and point of contact for all quality and safety inquiries by other William Grant Team members (in the US, Canada, and Mexico), business partners (foreign and domestic), and end consumers.

- Standardized all Testing methodologies and use of analytical equipment to better align with Global Processes

- Member of Global Business Model (GBM) Team for internal standardization of new ERP reporting software and all company related software

- Added statistical analysis and standardized reporting for Key Performance Indicators (KPIs) for all levels of the business, to include our facility in Guadalajara, Mexico, to bring about alignment with the Global Company Objectives

- Completed analytical project for internal Operations KPIs based on CAPA and trend analysis to bring about a minimum 60% reduction in major defects and non-conformances using Lean Six Sigma (LSS) methodologies

- Conducted supplier/contract packaging audits and reported back any non-conformities or observations to the Senior Leadership team, key stakeholders at William Grant and Sons, and our Suppliers to build better partnerships to improve overall product quality.

- Supported to maintain 0 Lost-Time Accidents (L.T.A. - OSHA Standard) for 3 years through developing training matrices based on all regulatory standards and training all members of production staff, including managers, through the use of leading indicators to prevent injury.

- Took Leadership Role on cross functional team to create, track, and achieve ambitious Global Company goals for 2017.

- Used root cause analysis to propose projects on increasing company efficiency and reducing the cost of quality and reported to key stakeholders and Senior Leadership team on its progress.

- Managed capital project for new equipment to an agreed upon timeline and held appropriate parties responsible for delays

- Manage Contracts and service agreements on key analytical equipment and schedule out Preventative Maintenance.

Pfizer Inc., Pearl River, NY March 2011 – April 2013 Aseptic Vaccines Operator

- Participated in “Right First Time” Initiative and “Operator Care” plan, as well as 5S and safety audits

- Maintain proper requirements in Class 100,000/10,000/100 areas

- Assisted other AVOs in Aseptic Filling Operation

- Assisted Vaccine Operators in the packaging department

- Aseptic Gown Certified

- Autoclave Operation

- Batch Record Maintenance and Review

- Maintain Logs of equipment use as required by corporation and regulatory agencies.

- Ensure Proper Gowning requirements are being followed

- Packaging/Warehousing of in-process and finished products Genzyme Biosurgery, Ridgefield, NJ September 2010 – March 2011 Aseptic Technician Assistant

- Contract through the Judge Group

- Assisted Aseptic Technicians in daily tasks

- Help train new personnel

- Inspection of in-process/finished products throughout production process

- Aseptic Gowning Certified

- Manipulation of product and key components in an ISO 5/Class100 area

- Ability to Read and comprehend Sterility Charts for production processes

- Operation of Autoclaves

- Maintain proper requirements in Class 100,000/10,000/100 areas

- Batch Record Maintenance and Review

- Maintain Logs of equipment use as required by corporation and regulatory agencies. ConAgra, Food and Ingredients, Cranbury, NJ April 2010- August 2010 Quality Assurance Laboratory Technician,

- Contract through Aerotek Scientific LLC.

- Quality control and Quality Assurance on products made on production line and pilot plant by subjecting samples to tests such as salt, density/specific gravity, moisture, fat content, protein content, scoville units (HPLC), Refractive Index, pH, Water Activity, Color.

- Check and maintain COAs and MSDS of ConAgra's products and raw materials

- Perform audits to maintain laboratory and warehouse sterility and ensure GMP, 5S, USDA, FDA, and customer compliance

- Calibrate Lab equipment daily

- Perform various tests on products (chloride analysis, refractability, pH, color, protein analysis) at various points in production process

- Engage in batch record review

- Input test results into LIMS for every product tested, as well as, analyze all data to discover trends and report to Manager.

- Create, Maintain, and organize laboratory standards for future comparison

- Create samples for olfactory, visual, and taste sampling

- Assist all members of QA and R&D department in daily tasks associated with QA/Regulation

- Review and follow HACCP, FDA, and/or USDA regulations and guidelines with all products

- Uphold ConAgra's chain of evidence and batch record analysis to ensure traceability ACTIVITIES:

Mentorship, Univ. of Sciences and Sigma Beta Rho Fraternity, Inc. August 2006 – Present

- Provided guidance and advice to younger students and fellow fraternity members on coursework, time management, and accountability

- Began career consulting seminars and one-on-ones with members to improve their candidacy for future positions. EDUCATION:

University of the Sciences of Philadelphia, Philadelphia, PA Major: Pharmaceutical Science Bachelor of Science May 2009

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