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Quality Assurance Specialist II Resume Example

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ChristineAwuor
Summary

Dedicated Quality Assurance professional who thrives under pressure and can make quick practical decisions while providing impeccable customer service. Able to absorb, sort, and analyze data with the ability to adapt quickly to changing environments. Able to support business growth and support the team in any additional ways to ensure strict deadlines are met. Proficient in Microsoft Office 2020 Suite (Word, Excel, PowerPoint, and Publisher), and quality management systems including NexLynk, TrackWise, and Master Control.

Experience
08/2021 - CurrentThermo Fisher Scientific Inc. - Device History Record ReviewerDenver , CO
  • Collaborated with cross functional teams to deploy the introduction of a medical device into the US market.
  • Trained in the requirements of FDA 21 CFR Part 820 and ISO 13845
  • Conducted audits on internal controls and developed reports on findings.
  • Improved customer review accuracy metrics by 90% by decreasing the percentage of errors.
  • Supported resolution for production issues related to DHR completion including non conformances, CAPAs, and deviations.
  • Worked closely with team members to deliver project requirements, develop solutions and meet deadlines.
  • A Subject Matter Expert for Device History Record (DHR) processes.
04/2020 - 06/2021Hyatt Hotels Corp. - Quality Assurance Specialist IILas Vegas , NV
  • Initiate investigations and reports any supplies that have not met quality specifications and requirements prior to use.
  • Collaborated with management to discuss effective plans for resolving major quality problems.
  • Contributed to business growth by confirming customer satisfaction with service and quality.
  • Trained in cGMP, CAPA investigation, SQuIPP, deviation management, quality support.
  • Trained in PPTA, 21 CFR (Parts 210, 211, 606, 640, 610, 11, 600, 601 subpart C) GHA, and CLIA requirements.
  • Verification and release of plasma sample shipment and biological waste shipments.
  • Reviews unsuitable test results and the disposition of the associated plasma units.
  • Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product.
08/2016 - 06/2020Biotest Plasma Center - Head ServerCity , STATE
  • Resolved customer issues for servers, consistently upholding professionalism and calmness to maintain customer satisfaction.
  • Trained new servers on menu items and restaurant standards.
  • Handled food safely and kept spaces clean to protect customers from foodborne illness and maintain proper sanitation.
  • Completed opening and closing checklists to facilitate smooth restaurant operations.
  • Reconciled cash register at close of business, verifying totals and quickly resolving discrepancies.
  • Served high volume of tables while simultaneously supervising serving staff.
  • Met or exceeded sales targets on consistent basis with proactive promotional strategies.
04/2018 - 04/2020Love To Swim And Tumble School - Phlebotomist II Team Lead, Quality Assurance AlternateCity , STATE
  • Provided training to donor floor staff for any audit findings, to improve plasma processing quality.
  • Promoted to leadership position in recognition of strong work ethic and provided exceptional customer service.
  • Ensures all necessary training is provided and completed for phlebotomists.
  • Trained in Phlebotomy and all proper PPE and lab safety protocols for the safety of donors and staff.
  • Reviewed specifications and directions carefully to determine precise set up for production equipment according to specifications.
  • Performs new and quarterly assessments for trained biomedical technician phlebotomists to determine if retraining is necessary.
  • Fostered positive employee relationships through communication, training and development coaching.
  • Integrated process improvements to increase overall workflow.
  • Documented production levels, materials used and special incidents to keep management informed of daily activities.
  • Kept work areas clean, neat and free of safety hazards to maximize efficiency.
  • Conducted inspections of equipment before, during and after shifts to immediately resolve any issues.
12/2012 - 12/2016Company Name - Site Supervisor, Head Swim Coach, Swim CoachCity, State
  • Most Improved Coach of the Year – 2013 Supervise and assist 3-6 coaches conducting lessons ensuring safety of students.
  • Developed new skills assessment tracking system which included a skills report grid for every student enrolled. This new tracking system went into use company wide and simplified the documenting and tracking process for students attained skills.
  • Demonstrated proper form and stroke technique to athletes in water for baby and me classes, preschool and school age, up to adult lessons.
  • Infant toddler trained and certified 2014.
  • Held keys to the building for opening and closing duties for the school.
  • Managed check in/out responsibilities.
  • Encouraged all students to perform at personal best using positive reinforcement.
  • Checked equipment and monitored common areas to maintain proper upkeep while remaining vigilant on safety.
  • Built strong media and community relationships through positive interaction and communication.
Skills
  • Inspections and audits
  • Materials/Product inspection
  • Quality Assurance
  • Staff mentoring
  • Correction plans
  • Safety procedures
  • Planning and coordination
  • People skills
  • Working collaboratively
Education
2021The University of TexasCity, StateB.S: Biology
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Resume Overview

School Attended

  • The University of Texas

Job Titles Held:

  • Device History Record Reviewer
  • Quality Assurance Specialist II
  • Head Server
  • Phlebotomist II Team Lead, Quality Assurance Alternate
  • Site Supervisor, Head Swim Coach, Swim Coach

Degrees

  • B.S : Biology

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