Ashley Magin
Huntsville,AL
Summary
Experienced microbiologist specializing in quality control and process improvement. Skilled at using data and analysis to identify and resolve issues. Dedicated to developing comprehensive solutions for process optimization and problem prevention.
Overview
11
11
years of professional experience
Work History
Senior Microbiology Scientist I
Integra LifeSciences
06.2022 - Current
- Conduct and support root cause investigations related to site-specific microbiological CAPAs and NCs
- Develop and support the implementation of corrective actions for site-specific microbiological CAPAs and NCs
- Develop global processes and procedures in alignment with biocontamination control industry standards
- Collaborate on the development of global facilities procedures in alignment with ISO standards to support product requirements
- Collaborated with leadership to develop and authored a global quality plan to address bacterial endotoxin issues at various manufacturing sites
Manager, Microbiology
Integra LifeSciences
02.2023 - 09.2023
- Active participant in 3 month FDA inspection
- Developed strategic plans to support remediation efforts of quality control and quality assurance
- Support of day-to-day operations of cleanroom environment
- Management, mentoring, and development of quality control and quality assurance staff
- Hiring of quality control and quality staff
Senior Microbiologist
Integra LifeSciences
06.2022 - 02.2023
Senior Technical Reviewer
Cambrex
10.2019 - 06.2022
- Perform technical data review of microbiological testing including but not limited to: bacterial endotoxin, microbial identification, sterility, bioburden, microbial limits, cytotoxicity of medical devices, drug products and/or water per USP and other standards.
- Perform technical data review of external client environmental monitoring testing data in accordance with ISO and EU standards.
- Development and review environmental monitoring performance qualifications for new or reestablished cleanrooms.
- Develop and conduct GxP training on the technical review of microbiological testing and environmental monitoring for individual employees and departments.
- Perform investigations for out-of-specification results/laboratory error for non-conformances and CAPA
- Review and approve technical parameters of SOPs, change controls, deviations, validations and external testing protocols/reports
- Perform user accessibility testing on new LIMS modules
Quality Control Microbiology Associate IV
B. Braun
08.2018 - 08.2019
- Performed sterility testing on finished products in an ISO 5 environment.
- Performed routine environmental monitoring in ISO 5, ISO 7 and ISO 8 environments.
- Performed bacterial endotoxin testing on raw materials and finished products.
- Performed bioburden testing on raw materials.
- Analyzed and documented results from sterility, routine environmental monitoring, bioburden, bacterial endotoxin testing on controlled documents and/or LIMS system
- Perform investigations for out-of-specification results/laboratory error for non-conformances and CAPA
- Developed and authored trend reports for routine environmental and finished product data
- Prepared and sterilized microbiological media and laboratory supplies
- Conducted training of new employees on laboratory tasks and SOPs
- Coordinated with cross-functional teams and departments to secure necessary documentation, lab supplies and/or equipment maintenance as well as other relevant information
Quality Assurance Coordinator/Microbiology Lab Supervisor
Vita-Herb Nutraceuticals
04.2018 - 08.2018
- Scheduled and developed testing plans of raw material and finished goods per production and customer demand
- Performed incoming raw material and finished good testing, review and disposition to ensure quality of material for production
- Investigated out of specification results of raw materials and/or finished products
- Oversaw and performed environmental monitoring of manufacturing and laboratory environments
- Coordinated pest control program
- Performed QA review of final product batch record and microbiological and chemical testing
- Generated and completed certificates of analysis for customers based on quality and product specifications
- Coordinated cGMP and GLP document revisions and updates
- Conducted employee cGMP and GLP training
- Managed QC microbiology personnel
Laboratory Coordinator
Kelly Scientific/Haliburton International Foods Inc.
07.2017 - 09.2017
- Development, redesign and implementation of environmental monitoring and trending programs
- Performed routine environmental monitoring of manufacturing environment
- Analyzed and trended data from routine environmental monitoring
- Development and implementation of laboratory inventory management system
- Development and training of microbiological and analytical laboratory testing SOPs
- Microbiological technical advisor for shelf-life studies and product commercialization
Microbiological Laboratory Teaching Assistant
CSU, Pomona
04.2014 - 03.2017
- Developed lesson plans based on core curriculum requirements to teach multiple sections of the general microbiology collegiate course
- Organized and prepared all microbiological media, microbial cultures and other materials necessary for laboratory session of the course
- Performed microbiological identification and trending of stock cultures to ensure quality control
- Developed and implemented test assessments
Education
Master's of Science - Biology Emphasis Microbiology
Cal Poly Pomona
Bachelor of Science - Biology
Boise State University (BSU)
Boise, IDSkills
- LIMS, Mastercontrol, Agile
- Microsoft Office Suite (PPT, Visio, Excel, Project)
- Statistical software (Excel, minitab)
- Technical Writing
- Project Planning
Timeline
Manager, Microbiology
Integra LifeSciences
02.2023 - 09.2023
Senior Microbiology Scientist I
Integra LifeSciences
06.2022 - Current
Senior Microbiologist
Integra LifeSciences
06.2022 - 02.2023
Senior Technical Reviewer
Cambrex
10.2019 - 06.2022
Quality Control Microbiology Associate IV
B. Braun
08.2018 - 08.2019
Quality Assurance Coordinator/Microbiology Lab Supervisor
Vita-Herb Nutraceuticals
04.2018 - 08.2018
Laboratory Coordinator
Kelly Scientific/Haliburton International Foods Inc.
07.2017 - 09.2017
Microbiological Laboratory Teaching Assistant
CSU, Pomona
04.2014 - 03.2017
Bachelor of Science - Biology
Boise State University (BSU)
Master's of Science - Biology Emphasis Microbiology
Cal Poly Pomona
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