Training Quality Control

JOHN MCWILLIAMS

**** ****** *****, ******, ***** 75249

Email: ****************@*****.***

Phone: 469-***-****

Objective

Seeking a position that will allow me to apply leadership skills within a team-oriented and diverse business environment

Education & Accomplishments

Paul Quinn College

Bachelor of Science -Business Administration/Management Graduated May 4, 2013

Valedictorian, Summa Cum Laude with a 3.95 GPA on a 4.0 scale

Texas Alpha Psi Chapter of the Alpha Chi National Honor Society, President

President’s Honor Roll List in 2012 & 2013

Kappa Alpha Psi Fraternity, Inc. – community project coordinator, mentor, member

Experience

Carroll Company November 2014-November 2015

Quality Control Manager

Maintained and performed GMP equipment calibrations, certifications and maintenance programs for the QC Lab and its equipment.

Participated in Customer and FDA audits for the facility

Audit and rewrite current procedures for the QC Lab. In addition, write new procedures, if needed

Oversee and manage all of Quality Control to make sure that organizational goals are being met

Initiate and investigate lab non-conformance reports of out-of-spec bulk and raw material products

Initiate and investigate supplier non conformance reports, CAPAs and Process Deviations

Managed testing and release of raw materials for production of various lotions, soaps and other household products.

Checks analytical data; including chromatographic spectra, HPLC runs, and calculations from raw material testing.

Supervises testing and release of bulk products and finished products for production of various lotions, soaps and other household products.

Checks analytical data (including HPLC runs and calculations for assay, content uniformity, and dissolution) from bulk product and finished product testing.

Writes specifications and test methods for raw material testing and QC Release testing.

Trains new lab personnel.

Evaluates potential new raw materials and products, as needed to support R&D.

Makes method and process improvements and participate in validation, a needed.

Performs other duties as required.

IBA Molecular, Inc.-Dallas, Texas October 2008-September 2011

Quality Assurance/Quality Control Lead

Analyzed samples from production runs by performing complete QC analysis; performed sterility analysis

Completed internal and external audits with FDA, customers and vendors

Assisted Project Management Teams with new equipment installs

Oversaw training documentation for new/current employees

Performed weekly and monthly safety audits

Accomplishments: Only one positive sterility result over three years; reduced re-samples from YY% to 5% per week and increased on-time sample results by 95%

Reduced operation errors decreased by over 50%

Investigate and write up reports for CAPAs

Ultrapure Solutions, Carrollton, Texas August 2007-May 2008

Batch Operator

Manufactured, labeled and packaged different size containers of chemicals per customer requests

0% failures on batches that were mixed according to customer specifications

Reviewed and signed off on all paperwork for each production run

American Red Cross, Portland, Oregon December 2005-April 2006

Lab Technician

Responsible for the processing of blood donations

As a lab technician, I was responsible for separating the blood from the plasma. I also was responsible for processing the blood portion through machines to check for conformity of the blood donations

Responsible for logging data into Computer and freezing the blood and plasma donations per lot numbers and expiration dates

Kanto Corporations, Portland, Oregon August 1997-February 2005

Production Supervisor and Training Coordinator

During my tenure at Kanto Corporations, I organized, led and trained staff on all job functions related to the production department

Created and put into effect a skill matrix which was used to help train operators on production tasks, this helped decrease the amount of operator errors within the production department by 90%

Attended daily and weekly staff meetings and worked closely with the departmental budget for production to reduce costs and save money within the production area

Responsible for performance reviews, interviewing, hiring and the dismissal of production employees

Performed internal/external customer audits for Kanto Corporations, which allowed me to serve my internal/external customers better

Responsible for leading the Daily Production Staff Meetings and worked closely with the Production Planning Department to plan production schedules on a daily and weekly basis. This allowed for increased efficiency in our daily and weekly planning schedules

Responsible for investigation of customer complain issues through CAPA. (investigating both internal and external customers)

Computer Skills

Operations Systems: Windows 2010, Lotus

Application Software: Microsoft Excel, Word, PowerPoint, Access, Basic SAP and Basic SharePoint

Professional Skills and Training

Managers, Supervisory and Lead Training, OSHA, FDA, Six Sigma Training, Lean Manufacturing Training and ISO 9000-9001 Quality Training. In addition, cGMP experience, cGLP experience, Aseptic experience and CAPA (Corrective And Preventive Action) experience.

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