Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
Generic

Tyler Mahan

Cary

Summary

Dynamic Quality Environmental Control Investigator at Pfizer with expertise in root cause analysis and regulatory compliance. Proven track record in conducting thorough investigations and developing protocols that enhance product safety. Skilled in data analysis and project management, driving impactful corrective actions to meet business objectives.

Overview

6
6
years of professional experience
1
1
Certification

Work History

Quality Environmental Control Investigator

Pfizer
Rocky Mount
06.2022 - Current
  • Conduct thorough M1 investigations on product safety and compliance issues.
  • Collaborate with cross-functional teams to analyze and interpret data.
  • Develop and review protocols for investigative processes and methodologies.
  • Facilitate training sessions for junior investigators on best practices.
  • Prepare detailed reports summarizing investigation findings and recommendations.
  • Perform an impact risk assessment, as well as root cause determination, and planning of appropriate corrective and preventive actions.
  • Coordinate and direct product disposition in accordance with agreed target dates and procedures to meet business needs.
  • Perform training for newly hired investigators, and also assist in the continuous training of investigators.
  • Perform auditing of SOPs, cGMP processes, cleanroom areas, and associated departments.

Microbiology Environmental Monitoring Lead

Nephron Pharmaceuticals
Columbia
02.2021 - 05.2022
  • Contributed innovative ideas and solutions to enhance team performance and outcomes.
  • Performed training for newly hired EM Technicians and continuous training.
  • Coordinated daily activities to monitor the environment, air quality, and personnel samples in the production area. Additionally, completed reviews of aseptic monitoring data entry and form completion.
  • Conducted and oversaw the completion of cleanroom audits.
  • Assisted in providing trend data and reports for analysis.
  • Assisted in the completion of media fills.
  • Maintained preventative maintenance for equipment inventory within the EM program.
  • Communicated quality-related observations, discrepancies, and any violations of FDA and company policies.

Microbiology Environmental Monitoring Technician

Nephron Pharmaceuticals
Columbia
01.2020 - 02.2021
  • Assisted in documenting and reporting deviations in manufacturing procedures.
  • Conducted routine inspections on equipment and systems for optimal performance.
  • Monitored production processes to ensure compliance with quality standards.
  • Maintained accurate records of equipment performance and maintenance schedules.
  • Communicated effectively with supervisors regarding operational issues and updates.
  • Documented quality discrepancies within the monitoring environment as well as any actions taken when responding to quality events.
  • Collected, tested, and submitted samples according to quality control standards.

Education

Bachelor of Science - Exercise Science

University of South Carolina
Columbia, SC
05-2017

Skills

  • Audit readiness
  • Root cause analysis
  • Risk assessment
  • Data analysis
  • Protocol development
  • Regulatory compliance
  • Project management

Certification

  • Lean Six Sigma Yellow Belt Certified
  • AI Mastery Certified

Languages

Spanish
Limited

Timeline

Quality Environmental Control Investigator

Pfizer
06.2022 - Current

Microbiology Environmental Monitoring Lead

Nephron Pharmaceuticals
02.2021 - 05.2022

Microbiology Environmental Monitoring Technician

Nephron Pharmaceuticals
01.2020 - 02.2021

Bachelor of Science - Exercise Science

University of South Carolina

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Tyler Mahan