My Resume
TECHNICAL PROFICIENCIES
Data Analytics | SQL | Tableau | MySQL | MS SQL Server | Microsoft Office | SharePoint | Python Trello | Confluence | Oracle | Lean | Agile | Scrum | Kaizen | Technical Writing | MasterControl Continuous Improvement | Good Laboratory and Manufacturing Practices (GLP/GMP)
PROFESSIONAL EXPERIENCE
Quality Systems Specialist II 06/2021 – 05/2022
BD | Sandy, UT
● Curated data from multiple databases to create an Adverse Event Reports to identify areas of concern, audit reports for accuracy and completeness, and create, and submit FDA reports according to federal schedules and regulations.
● Utilized data stewardship practices to ensure data provided to both internal and external parties reflected corporate and regulatory requirements.
● Collaborate with cross-functional teams to identify and develop resolutions for areas of concern and issues outlined in Adverse Event Reports.
Quality Assurance Auditor 10/2018 – 05/2021
Nelson Laboratories | Taylorsville, UT
● Compiled data utilizing both semi-structured and unstructured databases to identify environmental risk factors within laboratories, analyze raw testing data to ensure compliance with regulation and sponsor requirements, and detect and address negative trends using QMS event data.
● Acted as Data Validation team specialist to transition to automated documentation recording for data across multiple structured relations databases.
● Built reports from Oracle database to analyze and improve KPIs, resulting in 100% on-time training for the fiscal year and over 6 months of meeting or exceeding critical metrics.
● Performed monthly audits joining CRM data and sponsor feedback to analyze and develop strategies to maintain and/or improve sponsor satisfaction.
● Conducted testing and review of GLP data packs and identified out-of-range occurrences, and developed and implemented process improvements to decrease non-compliance issues.
Quality Assurance Manager 2015 - 2018 01/2014 – 08/2018
Innovative Labs (aka Innovative FlexPak) | Springville/St. George, UT
● Redesigned training database using fresh structural schemas to track training data and provide updates to department leadership in support of 100% on-time audit-ready training.
● Implemented defect trending database to collect scrap rate data, leading to faster identification of problematic areas and probable causes, resulting in scrap reduction rates of up to 15%
● Built SOP and training programs along with tracking databases to align better with compliance and production initiatives.
Training Supervisor 2014 - 2015
● Utilized existing and implemented new tracking databases to ensure SOPs were reviewed and revised in a timely manner, as well as ensuring employee refresher training was performed before expiration.
● Collaborated with key stakeholders to design and administer an employee orientation program to decrease new hire training time.
● Developed new SOPs and analyzed current SOPs to ensure proper alignment with company review policies.
Quality Assurance Manager 2013 - 2014 01/2009 – 01/2014
JEUNESSE (aka MonaVie) | South Jordan, UT
● Supported Quality Director activities including trending and analyzing budgets, tracking, researching, and developing R&D testing trending for tax initiatives.
● Managed a cross-functional team of 8 professionals and technicians within the Quality Control, Quality Assurance, and Document Control departments.
● Utilized testing trending and audit data to justify a skip-lot testing program, saving the company over $1 million dollars in testing expenses per quarter.
Quality Control Technician 2009 - 2013
● Created a department-wide structured relational database that generated automated reports and visualizations, saving the team 10-12 hours of manual reporting and trending time per week.
● Monitored product potency in real-time and accelerated testing to ensure compliance with label specs.
● Developed training programs and SOPs to increase efficiency, productivity, quality, and performance, and created a tracking database to monitor SOP revision and review.
Quality Assurance Technician 01/2007 – 01/2009
Nelson Laboratories | Taylorsville, UT
● Compiled raw laboratory data into structured reports and analyzed information for sponsors prior to completing FDA submission procedures.
● Conducted audits on incoming test data to identify compliance deficiencies and ensure adherence to GLP testing standards.
● Collaborated with Training department leaders to design, develop, and implement company-wide training materials including videos, presentations, FAQs, and procedural documents.
Quality Control Technician 01/2005 – 01/2007
a la mode, Inc. | Salt Lake City, UT
● Developed complex ad hoc SQL queries to gather data from multiple databases across SaaS environments utilizing Joins, Group By, Count, etc.
● Wrote and performed tests on SaaS offerings to identify security concerns and ensure consistent functionality across newly implemented software updates.
● Collaborated with clients and developers to identify, troubleshoot, diagnose, and resolve complex software issues.
EDUCATION & CERTIFICATION
Bachelor of Science – Westminster College – Salt Lake City, UT
Microsoft Azure Data Fundamentals Certificate – #I413-5529
ASQ Certified Quality Improvement Associate (CQIA) – #6396
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