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QA Specialist Resume Example

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QA SPECIALIST
Summary

Driven QA Specialist offering 3 years of experience in quality assurance. Skilled at optimizing production workflows, leading teams toward achievement of benchmarks and maintaining QA standards. Able to collaborate with groups or work independently with minimal supervision.

Skills
  • Internal Auditing
  • Personnel Management
  • SAP
  • Trackwise
  • Agile
  • Batch Record Review
  • Material Lot Disposition
  • Process Improvements (PPI)
  • Problem-solving skills
Experience
QA Specialist / Company Name - City, State01/2018 - Current
  • Monitored QA procedures for adherence by employees, notifying personnel of non-compliance issues.
  • Increased process improvement initiatives by troubleshooting problems for corrective action to boost functionality and workflow.
  • Consulted with management and personnel to educate on QA standards.
  • Performing routine Manufacturing batch record review and quality control data review in support of product releases.
  • Performed QA tours and inspections of the facilities and work ares to ensure that all EH&S/ Quality guidelines are adhered to.
  • Certified Internal Auditor to ISO 13485 upon completion of a 3 days Internal Auditing Workshop provided by the Quality SUpport Group. Served on the site Internal Auditing Team.
  • Utilizing the 8 Step PPI (Practical Process Improvement) Business Systems for processimprovements initiatives and Kaizen events.
  • Tracked problem reports via electronic deviation management system in Trackwise. Worked with both Process and QA owners in order to support timely closure of PRs to facilitate Lot Disposition for products affected.
  • Training new hire in the QA group for Batch Record Reviews, Material Disposition and Labeling. Provided guidance and coaching on other job related functions.
  • Attending daily Tactical/ Tier 4 meetings with site leadership and other cross functional work groups to provide Quality assurance updates and status of critical batch releases.
Lead Manufacturing Technician / Company Name - City, State09/2013 - 12/2017
  • Assisted in organizing the staff and workload to meet or exceed productivity performance in the Performance Optimized Polymer Manufacturing work centre
  • Directed the workflow of the team in support of the daily/weekly production schedule and tasks around product manufacturing and formulations
  • Provided functional supervision and assisted in the cross training of associates and new hires. Managed and measured work performance by tracking and assigning roles and responsibilities for tasks, set clear objectives and providing real time feedback to staff
  • Under the direction of the area supervisor: Facilitated and directed team meetings, identified training and personnel skill enhancement opportunities, participated in project meetings, screening potential candidates and conducting interviews as a panel member
  • Set-up/calibrate/operate processing and packaging equipment to manufacture polymers and other consumables for genetic sequencing instrumentation's. Equipments trained to includes: Vessels, mixers, pouch filling system, heat sealers, peristaltic pumps, filtration systems, Delta V control systems and various packaging equipments.
  • Initiated deviation reports and performing investigations, root cause analysis using Trackwise electronic deviation management system.
  • Initiated ECRs/ECOs via Agile to update, write and revise SOPs, Batch records and UOPs.
Stamping Press Operator / Company Name - City, State02/2007 - 09/2013
  • Adhered to all standard operating procedures and complied with safety and quality processes.
  • Operating stamping press equipment to which imprint designs, lettering's, numbers and customer's logo onto surfaces of materials such as paper and cloth using colored foils prior to being bound into book
  • Responsible for the set-up and production of work orders according to customer's specifications
  • Responsible for the in-process inspection of the quality of each embossed/stamped cases and and daily production requirements
  • Responsible for the troubleshooting of stamping press issues that arise and performing routine preventative maintenances in order to avoid equipment down-time occurrences. Worked along side maintenance personnel's to facilitate equipment fixes and ordering of parts needed.
  • Was licensed with the company to operate various forklifts in order to support transport of raw materials to and from the equipment to various areas in the plant
  • Utilized as needed to support inline packaging, inspection fr materials defects in the Bindery, palletizing packaged goods for shipment preparations.
Education and Training
Lowell High School - City, State06/2006High School Diploma
Military Experience

Massachusetts Army National Guard

1-182 IN Regiment 2005-2018 and 2020-present

MOS: Infantry

  • 1 tour of duty to Afghanistan 2011-2012 in support of Operation Enduring Freedom.
  • Served as a Team leader supporting the growth and development of junior team members in an infantry Squad/Platoon. Provided training and counseling based on Company directives and training plans.
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Resume Overview

School Attended

  • Lowell High School

Job Titles Held:

  • QA Specialist
  • Lead Manufacturing Technician
  • Stamping Press Operator

Degrees

  • Lowell High School - City, State 06/2006 High School Diploma

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