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Quality Specialist Resume Example

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QUALITY SPECIALIST
Professional Summary

CAREER SUMMARY Customer oriented Quality Specialist with several years of progressive quality assurance experience in the cosmetic, pharmaceutical, medical device and food and beverage industries. Proficient in reviewing, maintaining, and monitoring quality programs. Effectively performs quality control tests and reviews to ensure customer specifications are met. Highly skilled in computers including MS Office Suite and Quality Testing Software.

Skills
  • Quality Assurance & Control
  • Batch Record Review
  • Microbiological Media Prep & Testing
  • Good Documentation Practices (GDP)
  • Good Manufacturing Practices (GMP)
  • In Process Quality Inspections
  • Analytical Testing
  • 21 CFR 210, 211, 820
  • ISO 13485:2016
  • Certificate of Analysis Creation
  • Raw Material Sampling & Inspection
  • Water Sampling
  • Equipment Calibration
  • AS400
  • QA Studio Laboratory Information Systems
Work History
March 2019-CurrentQuality Specialist | Scapa Healthcare | Dallas, Texas
  • Perform batch record review and finalize all documentation for product release for 30 customers in accordance with specifications and SOPs decreasing turnaround time of release by 10%
  • Create/Review/Approve Certificate of Analysis according to customer specification
  • Follows all regulatory guidelines, cGMP guidelines, and aseptic techniques as required by job function
  • Conduct product release activities for drug substances, intermediates, drug product and finished goods for all phases of development including review and approval of master batch records and executed batch records
  • Cross train production leads in in process inspections related to customer specification
  • Coordinate with Supply Chain team to prioritize reviews based on production and shipment schedules
  • Collaborate with Quality and Manufacturing personnel to correct errors and address Non-Conformances in a timely manner
  • Act as back up for Quality Control Technicians which includes quality production floor checks, calibrations, raw material inspection, housekeeping documentation and release and water sampling
  • Record and organize test data for report generation and analysis
  • Coordinate third party inspections for customers as it relates to Pro QC releases
June 2018-January 2019Quality Assurance Lead | National Food and Beverage, LLC | Dallas , Texas
  • Review all quality related paperwork to ensure product was released with in specification results
  • Provide support for Quality Assurance Technicians during times of short staff
  • Check all recording charts for Hazard Analysis Critical Control Point deviations
  • Inspect and investigate any customer complaints reporting concerns to supervisor for further instruction
  • Inspect incoming raw materials for release and investigating any non conforming raw materials shipped by supplier
  • Complete first article checks for production lines to ensure proper start up eliminating quality issues
  • Perform Pre-Operational Inspection prior to facility being released for production
  • Perform swabbing activities for environmental monitoring program assisting in establishing alert and action limits
October 2017-June 2018Quality Assurance Technician | Ventura Foods | Fort Worth, TX
  • Test, monitor, and document accurate quality results and processing data for products produced
  • Audit, verify and follow-up process controls such as weight checks, batch sheets, HACCP, plant inspections, receiving, etc
  • Support process variations related to formula adjustments to satisfy customer requirements
  • Maintain high and effective level of communication with all operating departments
  • Operate, calibrate, and maintain lab equipment
  • Ensure that all GMP, sanitation, and housekeeping practices are being followed according to established procedures
  • Understand and apply functionality of site's Hold Program to ensure non conforming product is quarantined and segregated
  • Utilize AS400 computer system for necessary quality functions
  • Maintain and complete files and documentation accurately and timely
December 2007-August 2017Lab Technician | Oak Farms Dairy | Dallas, Texas
  • Perform sampling of raw materials and in-process and finished products
  • Calibrate and maintained laboratory instrumentation
  • Sanitize and maintain lab utensils, glassware, equipment and media
  • Prepare and stock reagents and media to ensure inventory levels were adequate for on time testing
  • Evaluate monitoring records of all lab analytical testing
  • Initiate out of specification reports for non-compliant laboratory testing results
  • Perform chemical, physical and microbiological testing of raw materials, in-process and finished products
  • Manage laboratory reports in a timely, accurate and legible manner
  • Perform area release for laboratory prior to testing ensuring areas were orderly and clean
  • Adhere to all Dean Foods Safety and Quality policies and procedures, reporting any nonconformity
  • Audit plant conditions to ensure compliance standards and specifications maintained
Education
2002High School Diploma: Duncanville High School , Duncanville, TX
Sam Houston University, Huntsville, Texas
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Resume Overview

Companies Worked For:

  • Scapa Healthcare
  • National Food and Beverage, LLC
  • Ventura Foods
  • Oak Farms Dairy

School Attended

  • Duncanville High School
  • Sam Houston University

Job Titles Held:

  • Quality Specialist
  • Quality Assurance Lead
  • Quality Assurance Technician
  • Lab Technician

Degrees

  • High School Diploma :

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