Summary
Overview
Work History
Education
Skills
Certification
Affiliations
Websites
References
Timeline
Generic

Thomas Wagler

1012 East Hatch Street Sturgis,MI,

Summary

Quality Engineer with 6 years of experience in water quality management, distribution systems, and regulatory compliance. Certified Waterworks System Operator with expertise in HACCP, SQF, sanitation programs, and lab testing. Skilled in utilities and facilities design, validation, and CAPA processes to drive continuous improvement and ensure operational excellence. Proven track record of optimizing systems and maintaining high safety and quality standards.

Overview

6
6
years of professional experience
1
1
Certification

Work History

Quality Engineer

Abbott
Sturgis, MI
01.2023 - Current
  • Directed cross-functional teams to uncover root causes of quality issues and execute corrective measures.
  • Performed statistical analyses and compiled data to support continuous improvement initiatives.
  • Partner with various departments to optimize quality management systems.
  • Create and implement validation packages on new equipment and facility upgrades.
  • Corrected discrepancies discovered during the validation process.
  • Routinely train team members on practices and procedures to maintain quality standards.
  • Respond to regulatory inspection observations, and address remediation activities.

Document Control Specialist

Catalent (Formerly Bettera Brands)
Greendale, IN
05.2021 - 12.2022
  • Developed and implemented a comprehensive document control system to ensure accurate and efficient management of project documentation.
  • Performed regular audits of document control processes and procedures to identify areas for improvement, and implement necessary changes.
  • Collaborated with various departments to coordinate the review, approval, and distribution of critical documents, to ensure the timely completion of projects.
  • Maintained and updated electronic databases and filing systems to track and organize all project documentation in a secure and accessible manner.
  • Provided training and support to team members on document control protocols and systems to ensure compliance with industry standards and regulations.
  • Conducted regular audits of documents for accuracy, consistency, and completeness.
  • Provided technical assistance when needed in order to troubleshoot any issues related to document control operations.

Quality Systems Specialist

Wannemacher Total Logistics
Van Wert, OH
05.2019 - 04.2021
  • Served as backup to the Quality Manager, with duties such as batch record review, product testing review, and product label acceptance.
  • Maintained documentation system activities through a self-created EDMS (Electronic Document Management System).
  • Developed and implemented quality assurance processes to ensure compliance with industry standards and regulations.
  • Conducted regular audits and inspections to assess the effectiveness of quality control systems.
  • Collaborated with cross-functional teams to monitor key performance indicators, and drive continuous improvement initiatives.
  • Implemented corrective and preventive actions to address third-party benchmark inspection observations, internal audits, and weekly management reviews.
  • Prepared reports summarizing quality system performance metrics for management review.

Education

Bachelor of Arts - Biology - Chemistry Minor

Bluffton University
Bluffton, Ohio
05.2019

Skills

  • Knowledge of FDA Audit Processes
  • Regulatory Compliance Management
  • Validation (Parts 111, 117, and 11)
  • Failure Mode and Effects Analysis (FMEA)
  • Root Cause Analysis (RCA)
  • Hygiene Standards Management
  • Internal Audit Analysis
  • Corrective Action, Preventive Action (CAPA)
  • Water Systems Analysis
  • Cross-Connection Monitoring
  • Local and Federal Health Department Compliance
  • Water Quality Standards Expertise

Certification

  • Safe Quality Food (SQF) Training, Alchemy Academy, October 2019
  • Hazard Analysis and Critical Control Points (HACCP) Certification, HACCP Consulting Group, January 2019
  • Internal Auditing Certification - ISO 19011, AGET Global Consulting, January 2019
  • Preventative Controls Qualified Individual (PCQI), ABI International, July 2022
  • Process Validation Life Cycle Training, Cobblestone (formerly CfPA), February 2022
  • Waterworks System Operator Certification, EGLE (Environmental, Great Lakes, and Energy), State of Michigan, November 2023

Affiliations

  • Volunteering with Abbott Outreach Programs, including Future-Well Kids and Abbott Science Night
  • Abbott Early Career Network (AECN) Participant

References

References available upon request.

Timeline

Quality Engineer

Abbott
01.2023 - Current

Document Control Specialist

Catalent (Formerly Bettera Brands)
05.2021 - 12.2022

Quality Systems Specialist

Wannemacher Total Logistics
05.2019 - 04.2021

Bachelor of Arts - Biology - Chemistry Minor

Bluffton University

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Thomas Wagler