Caitlin Mangan
Bath
Summary
A laboratory manager with experience in regulatory compliance and innovative testing methods. Passionate about delivering actionable insights and driving continuous improvement in laboratory operations.
Overview
13
13
years of professional experience
Work History
Laboratory Manager
Gillson Sciences LLC
Schnecksville
2021.12 - Current
- Collaborate in planning and directing lab operations to meet regulatory standards and improve turnaround time with measurable results.
- Advise clients on testing methods and result interpretation, producing actionable trend analyses that inform client decisions.
- Develop and oversee a comprehensive training program that standardizes technical competency and reduces onboarding time.
- Perform investigations and lead CAPA activities to resolve nonconformances and prevent recurrence with documented outcomes.
- Ensure all technical staff follow policies and procedures to maintain compliance and consistent laboratory performance.
- Collaborate on research and implement new testing methods and validations to expand service offerings and ensure method reliability.
Senior Microbiologist
Gillson Sciences LLC
Schnecksville
2016.06 - 2021.12
- Performed and analyzed tests utilizing aseptic techniques.
- Conducted analysis of environmental monitoring samples to ensure compliance.
- Prepared water samples according to EU and USP guidelines; performed analyses on Total Organic Carbon, pH, conductivity, and endotoxin levels.
- Set up and analyzed medical device testing for quality assurance.
- Conducted USP sterility testing to validate product safety.
- Performed microscopy for mold identification and microphotography.
- Executed Microbial Limits Testing in accordance with USP guidelines.
- Reviewed and maintained records to ensure compliance with laboratory specifications.
Operations Lead
Merieux Nutrisciences
Allentown
2016.02 - 2016.06
- Ensure all departments opening and closing tasks are completed effectively and efficiently and documented as quality systems require.
- Assist with scheduling and adjusting staff as needed based on sample volume.
- Support laboratory leadership in employee development by providing efficient training to new employees.
- Ensure client specific requirements are being met.
- Work with supervisor on identifying and correcting performance issues.
- Communicate with other departments as well as management on department needs.
Microbiologist
Merieux Nutrisciences
Allentown
2013.09 - 2016.02
- Perform microbiological testing for food according to FDA, USP, USDA methods.
- Extensive knowledge and experience detecting pathogens using PCR and ELISA technology.
- Prepare technical reports and summaries based upon testing outcomes.
- Perform daily quality controls and calibration procedures to maintain proper validation.
- Perform confirmation testing for suspect samples to identify the strains of bacteria.
- Responsible for following GDP, GMP, and GLP procedures and protocol.
- Familiar with compliance testing standards ISO/IEC 17025:2005.
Education
BS - Natural Science
Indiana University of PA
Minor - Chemistry
Indiana University of PA
Skills
- AOAC/FDA Standards
- ISO 17025
- USP Methods
- ANSI/AAMI/ISO 11737:2018
- Zen QMS
- Zetasafe Compliance Software
- Laboratory Information Management Systems
Timeline
Laboratory Manager
Gillson Sciences LLC
2021.12 - Current
Senior Microbiologist
Gillson Sciences LLC
2016.06 - 2021.12
Operations Lead
Merieux Nutrisciences
2016.02 - 2016.06
Microbiologist
Merieux Nutrisciences
2013.09 - 2016.02
BS - Natural Science
Indiana University of PA
Minor - Chemistry
Indiana University of PA