Summary
Overview
Work History
Education
Skills
Timeline
Generic

Michael Livingston

Quality Assurance Auditor
Columbus,OH

Summary

Quality Assurance professional with a strong background in process evaluation, corrective action planning, and risk management. Adept at using root-cause analysis to identify process inefficiencies and implement creative solutions to ensure regulatory success. Demonstrates unwavering reliability and adaptability, thriving in dynamic environments to meet Client needs and achieve operational objectives.

Overview

12
12
years of professional experience

Work History

Quality Assurance Auditor I

AmplifyBio
06.2023 - 04.2025
  • Conducted 223 In-process, Critical Phase, Study File and Facility Area/Record audits applying a risk-based audit approach to identify areas of process improvement and highlight GLP non-compliances.
  • Issued audit reports in an efficient and timely manner, recommending corrective actions to study teams and Testing Facility Management while providing quality and regulatory guidance to process improvement initiatives and improving operational efficiency.
  • Contributed to the development of non-clinical Study Protocols, ensuring study designs achieved research objectives, were regulatory compliant, and adhered to current ethical standards and regulations.
  • Ensured the reporting of non-clinical studies accurately reflected the raw data and adhered to the Study Protocol, GLP and relevant SOPs.
  • Managed Veeva document workflows to author and revise SOPs for the Quality Assurance Unit. Reviewed and edited SOPs for other functional areas providing feedback and mentoring to staff regarding SOP structure, regulatory compliance, and process improvement.
  • Audited equipment qualifications and system validations ensuring all records (IQ, OQ, PQ, Trace Matrix, Evidence Sheets, etc.) adhered to the Qualification/Validation Plan, were accurately reported, and met the intended use to support non-clinical study objectives.
  • Developed and administered training materials for the Quality Assurance Unit for Provantis In-Life, Pathology, and Data Table audit.

Data Coordinator (Quality Operations)

AmplifyBio
10.2021 - 05.2023
  • Managed over 30 study files with precision, ensuring timely record review and prompt resolution of data discrepancies through meticulous investigation and collaboration.
  • Leveraged previous laboratory experience to enhance data accuracy, streamlining data collection templates and identifying areas of process improvement or increased oversight.
  • Established strong relationships with Study Management, Client Representatives, and laboratory staff to facilitate collaborative research efforts and meet study objectives.
  • Demonstrated resourcefulness in navigating unexpected challenges such as changes in project scope or budget constraints.
  • Developed and administered training program for 11 Study Directors, 13 Study Coordinators, and 15 Data Coordinators regarding data collection and reporting in the Provantis system, increasing overall Department efficiency and improving inter-department collaboration.

Pathology Data Coordinator (Senior Technician)

AmplifyBio
05.2021 - 10.2021
  • Provided strategic guidance during GLP and non-GLP Protocol development, leveraging subject area expertise to ensure alignment with departmental standards and organizational objectives.
  • Managed 12 Pathology study files, ensuring data integrity and adhering to Study Protocol, departmental standards, and regulatory guidelines.
  • Scheduled and led study progress meetings with pathology staff and coordinated deliverables to off-site pathologists.
  • Collaborated with Study Management to prepare deviations and reconcile audit findings through meticulous investigation and collaboration with cross-functional groups.
  • Captured data quality metrics, identified/escalated adverse trends, and collaborated with other departments to clarify discrepancies and improve future documentation.
  • Continuously mentored pathology staff in data collection and review within the Provantis system.
  • Led process improvement initiatives within the histology laboratory by revising Standard Operating Procedures, streamlining documentation templates, and providing laboratory signage to reinforce documentation standards and improve laboratory efficiency.
  • Assisted necropsy staff with tissue collections as needed.

Anatomic Pathology Technician

Battelle Memorial Institute
07.2017 - 05.2021
  • Developed a diverse necropsy skill set performing an average of 20 necropsies per month in BSL2 and BSL3 laboratories and assisting trim and histology teams with deliverables when not in necropsy.
  • Created and maintained 46 pathology study files, ensuring prompt record review and guaranteeing data integrity standards and study objectives were met.
  • Collaborated with Study Management to reconcile data discrepancies and ensure prompt resolution for adverse audit findings.
  • Streamlined department documentation, improved data integrity, and increased department efficiency by leading the transition from paper to electronic data documentation within the Pathology department.
  • Developed and implemented a Provantis data collection training program for 25+ technicians, Pathology Management, and multiple off-site pathologists.

Laboratory Animal Technician

Battelle Memorial Institute
09.2016 - 07.2017
  • Assisted other laboratory animal staff to perform animal husbandry, administer test article, and collect biological samples on ~3-5 studies per week.
  • Ensured study critical end-points were collected appropriately in accordance with the protocol, Good Laboratory Practice (21.CFR.58), and standard operating procedures.
  • Identified and escalated study/facility non-conformances to Study Coordinators and Study Directors to ensure prompt risk assessment for study integrity.

Retail Sales Associate

Teavana, Eddie Bauer, J.Crew, Helzberg Diamonds
06.2013 - 09.2016
  • Greeted customers and helped with product questions, selections and purchases.
  • Supported efficient and timely replenishment of sales floor merchandise.
  • Answered questions about store policies and addressed customer concerns.
  • Volunteered for extra shifts during holidays and other busy periods to alleviate staffing shortages.
  • Trained new associates on cash register operations, conducting customer transactions and balancing drawer.
  • Opened and closed store independently and prepared nightly bank drop for manager.

Education

Bachelor of Science - Biology

Lourdes Universtiy
Sylvania, OH

Skills

Regulatory Compliance

Risked-based Auditing

Conflict Resolution

CAPA Implementation

Document Management

Training and Coaching

Root-cause analysis

Continuous improvement

Timeline

Quality Assurance Auditor I

AmplifyBio
06.2023 - 04.2025

Data Coordinator (Quality Operations)

AmplifyBio
10.2021 - 05.2023

Pathology Data Coordinator (Senior Technician)

AmplifyBio
05.2021 - 10.2021

Anatomic Pathology Technician

Battelle Memorial Institute
07.2017 - 05.2021

Laboratory Animal Technician

Battelle Memorial Institute
09.2016 - 07.2017

Retail Sales Associate

Teavana, Eddie Bauer, J.Crew, Helzberg Diamonds
06.2013 - 09.2016

Bachelor of Science - Biology

Lourdes Universtiy

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Michael LivingstonQuality Assurance Auditor