JULIANNE COLE
Boston,MA
Summary
Professional Laboratory Manager with experience maintaining smooth and efficient QC laboratory operations. Focused on continuous improvement, problem-solving, and technical expertise. Decisive and dedicated professional with a quality-driven mindset. Exceptional management skills and proven history of effective leadership.
Overview
9
9
years of professional experience
Work History
QC Lab Manager
Azurity Pharmaceuticals
01.2023 - Current
- Oversaw day-to-day laboratory operations; including scheduling, sample release, inventory management, equipment qualification, training, and reporting metrics
- Provided leadership, insight, and mentoring to QC organization to ensure compliance, efficiency, and drive improvements
- Conducted and ensured timely completion of laboratory investigations, deviations, CAPAs, method transfers, and technical reports
- Managed ICH compliant stability program
- Oversaw Environmental Monitoring Program, including review of EM data, excursion investigations, and trend reports
- Implemented validation of Excel spreadsheets used for GMP calculations
- Developed team members' knowledge and skills to improve performance and expand capabilities
- Held regular one-on-one meetings with employees to review performance and priorities and provide feedback
- Evaluated quality metrics to monitor laboratory performance and identify areas for continuous improvement
- Collaborated with cross-functional teams to ensure timely and successful completion of projects
- Represented QC Laboratory in regulatory and internal quality inspections.
QC Senior Microbiologist
Azurity Pharmaceuticals
08.2021 - 01.2023
- Established Environmental Monitoring Program for cleanrooms; including authoring risk assessment, new SOPs, qualification protocol, and quarterly trend reports
- Developed, validated, and implemented new microbiological testing methods, including microbial limits testing and water bioburden.
- Reviewed and approved Certificates of Testing for release of routine test samples
- Streamlined and managed sample receipt process to ensure on time testing and release of samples
- Trained junior microbiologists on proper aseptic techniques and laboratory protocols
- Coordinated with other departments such as Quality Assurance, Regulatory Affairs, Manufacturing, and R&D for successful execution of projects
- Performed routine testing including microbial limits testing, antibiotic potency testing, pH, growth promotion, bioburden, TOC, and gram staining.
QC Microbiologist
Azurity Pharmaceuticals
08.2020 - 08.2021
- Led method transfer for USP Antibiotics - Microbial Assays and successfully established routine testing
- Performed routine microbiological testing of raw materials, in-process and finished products according to established procedures
- Monitored inventory levels of lab supplies, reagents, and other materials needed for QC Microbiology operations
- Created new SOPs for microbiological test methods and equipment, including growth promotion, plate counting, and gram staining
- Created Certificates of Testing for release of routine test samples
- Ensured calibration and qualification of laboratory equipment was performed on time.
QC Microbiology Analyst III
Ocular Therapeutix
09.2019 - 08.2020
- Coordinated microbiological testing of cleanrooms and products with contract labs
- Authored environmental monitoring trend reports for cleanrooms, RODI Water System, and utilities
- Led investigation team for environmental monitoring, bioburden, sterility, and endotoxin excursions
- Performed risk assessment to reduce routine environmental monitoring sites
- Managed quarterly dose audit program for clinical and commercial products.
Microbiologist – CEA Administrator
Medtronic
12.2017 - 09.2019
- Managed qualification and routine environmental monitoring of numerous cleanrooms and deionized water systems
- Authored protocols, investigations, and trend reports for cleanrooms and used statistical analyses to evaluate data
- Ensured environmental monitoring programs remained compliant to applicable ISO standards
- Implemented site improvement initiatives, including executing cleaning validations of cleanrooms
- Represented site cleanrooms in both internal and external audits
- Participated in several CAPAs to drive improvement
- Advised several Medtronic sites on completion of cleanroom qualifications and implementing risk based environmental monitoring programs
- Served as system administrator for Laboratory Information Management System (Labware LIMS).
Associate Microbiologist
Medtronic
07.2016 - 12.2017
- Performed routine microbiological tests including environmental monitoring of cleanrooms, ethylene oxide sterilization, bioburden, sterility, sterilization validation, bacterial characterization, and HPLC analysis
- Responsible for general laboratory housekeeping, including growth promotion of media, preparation of microbiological media, sterilization of laboratory equipment, and laboratory cleaning
- Participated in 5S efforts to lean out and standardize laboratory workflows
- Performed quality review of sterilization data for release of product.
Associate Microbiologist
BioTechnique LLC
05.2015 - 07.2016
- Performed testing in cGMP setting including environmental monitoring of cleanrooms, bioburden, bacterial endotoxin, bacterial identification, biological indicator, TOC, and conductivity.
- Participated in qualification of new cleanrooms, RODI Water System and Compressed Air System.
- Assisted with method validations for sterility, bioburden, and endotoxin testing.
- Organized and managed skill based training of new Quality Control Laboratory personnel.
- Consulted for environmental monitoring projects at other biotechnology companies in the Madison area.
Education
Bachelor of Science - Molecular, Cellular, and Integrative Biology
Beloit College
Beloit, WI05.2015
Timeline
QC Lab Manager
Azurity Pharmaceuticals
01.2023 - Current
QC Senior Microbiologist
Azurity Pharmaceuticals
08.2021 - 01.2023
QC Microbiologist
Azurity Pharmaceuticals
08.2020 - 08.2021
QC Microbiology Analyst III
Ocular Therapeutix
09.2019 - 08.2020
Microbiologist – CEA Administrator
Medtronic
12.2017 - 09.2019
Associate Microbiologist
Medtronic
07.2016 - 12.2017
Associate Microbiologist
BioTechnique LLC
05.2015 - 07.2016
Bachelor of Science - Molecular, Cellular, and Integrative Biology
Beloit College
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