Ferring Pharmaceuticals, Quality Control Department
1
Language
1
Certification
12
years of professional experience
Professional microbiologist with focus on quality control microbiology. Proven experience in maintaining high standards and ensuring compliance with regulatory requirements. Known for effective teamwork and flexibility in dynamic environments. Skills include microbial testing, aseptic technique, and data analysis.
Work History
QC Microbiologist
3 Years 9 Months
Ferring Pharmaceuticals, Quality Control Department | 11.2022 - Current
Conducted microbiological testing to ensure compliance with regulatory standards.
Implemented quality protocols for raw materials and finished products.
Ensured regulatory compliance with FDA, EPA, and ISO guidelines through strict adherence to protocols and proper documentation.
Developed and optimized laboratory procedures to enhance testing accuracy.
Trained junior staff on microbiological techniques and safety protocols.
Led investigations into product deviations, identifying root causes and corrective actions.
Performed environmental monitoring for manufacturing areas.
Implemented Biosafety level II safety plan for the laboratory.
Monitored environmental monitoring programs to maintain a controlled manufacturing environment.
Assisted in continuous improvement initiatives by identifying areas of concern within the QC Microbiology department.
Performed trend analysis on historical data, identifying potential areas for improvement in microbial control strategies.
Collaborated with cross-functional teams to address product quality issues related to microbiology.
Supported facility audits by providing comprehensive documentation of microbiological tests and results.
Ordered laboratory equipment and supplies.
QC Microbiologist
3 Years 3 Months
Fagron Inc, Quality Control Department | 08.2019 - 11.2022
Ensured regulatory compliance with FDA, EPA and ISO guidelines through strict adherence to protocols and proper documentation.
Conducted microbiological testing to ensure compliance with regulatory standards.
Implemented quality control protocols for raw materials and finished products.
Trained junior staff on microbiological techniques and safety protocols.
Developed and optimized laboratory procedures to enhance testing accuracy.
Led investigations into product deviations, identifying root causes and corrective actions.
Collaborated with cross-functional teams to improve overall quality assurance processes.
Managed documentation of test results in compliance with GMP requirements.
Assisted in continuous improvement initiatives by identifying areas of concern within the QC Microbiology department.
Improved product quality by implementing rigorous QC testing procedures for microbiological analysis.
Supported facility audits by providing comprehensive documentation of microbiological tests and results.
Reduced contamination risks by maintaining a clean and organized laboratory environment.
Ordered laboratory equipment and supplies.
Regulatory Data Specialist
8 Months
Pace Analytical, Regulatory Services | 12.2018 - 08.2019
Analyzed complex data sets to support regulatory compliance efforts.
Developed and maintained data management systems for streamlined operations.
Collaborated with cross-functional teams to ensure accurate data reporting.
Consistently met deadlines and delivered high-quality work, demonstrating a strong commitment to excellence in data management.
Maintained files, records, and chronologies of entry activities.
reviewed and updated client correspondence files and database information to maintain accurate records.
Scanned documents and saved in the database to keep records of essential organizational information.
Managed sensitive information responsibly, adhering to strict security protocols and maintaining confidentiality at all times.
Assisted in meeting regulatory requirements by ensuring proper documentation and adherence to data governance policies.
Laboratory Supervisor
1 Year 7 Months
Pace Analytical, 3M Food Safety Department | 04.2017 - 11.2018
Supervised laboratory operations ensuring compliance with safety and quality standards,
Trained and mentored staff on laboratory procedures and best practices.
Collaborated with teams to evaluate and enhance laboratory personnel performance and organization.
Developed and implemented process improvements to enhance workflow efficiency.
Managed scheduling and resource allocation for laboratory projects.
Conducted performance evaluations fostering team development and accountability.
Collaborated with cross-functional teams to align projects with organizational goals.
Mentored junior staff members to foster professional growth, skill development, and career advancement opportunities within the organization.
Quality Assurance and Manufacturing Microbiologist
1 Year 10 Months
Pace Analytical, 3M Food Safety Department | 01.2017 - 11.2018
Conducted microbial analysis to ensure food safety compliance and quality control standards.
Implemented quality assurance protocols, ensuring adherence to regulatory requirements and industry standards.
Collaborated with cross-functional teams to troubleshoot laboratory equipment and processes.
Trained junior staff on microbiological techniques and best practices in laboratory settings.
Validated test methods and new products and inspected products for defects.
Managed microbial specimens (yeast, molds, bacteria) for plating and analysis.
Validated test methods and new products while inspecting for defects, ensuring high-quality standards for product release.
Research and Development Microbiologist
3 Years
Pace Analytical, 3M Food Safety Department | 12.2014 - 12.2017
Proficiently generated, compiled and documented experimental data to support verification efforts and product launches for five molecular pathogen detection assays.
Supported R&D and post-launch troubleshooting for multiple pathogen and Petrifilm indicator organism product platforms, enhancing product reliability.
Executed microbiology and molecular laboratory tasks, including gram staining, media preparation, and biochemical testing, ensuring accurate results for product development.
Collaborated with Quality, Regulatory, Tech Service, and R&D teams to streamline product development processes, facilitating timely project completion.
Routinely utilized Microsoft Office, Excel, and PowerPoint to generate technical reports and presentations.
Education
Bachelor of Science (B.S.) - Biology, Microbiology
Minnesota State University, Mankato | Mankato | 12-2014
Dean’s List, Spring 2012
Volunteer: Science fair judge elementary level
Skills
Microbial identification
Sterility testing
Microbiological techniques
Gram staining
Microbial enumeration
Growth promotion testing
Bioburden testing
Environmental monitoring
Quality control
Manufacturing practices
Bioassay development
Data Analysis
Data analytics
Laboratory safety protocols
Data analysis
Laboratory Management
Contamination Control
Project Management
Team collaboration
Detail orientation
Adaptability
Microscopic analysis
Quality Control
Quality Control
Certification
HAZWOPER 40-Hour
Foundations of Project Management
HACCP
Lean Six Sigma Green Belt
Occupational Safety and Health Professional 132-Hour
Adult/Child First Aid (AED)
Languages
Spanish
Limited Working
Timeline
QC Microbiologist
Ferring Pharmaceuticals, Quality Control Department
11.2022 - CurrentRead More
QC Microbiologist
Fagron Inc, Quality Control Department
08.2019 - 11.2022Read More
Regulatory Data Specialist
Pace Analytical, Regulatory Services
12.2018 - 08.2019Read More
Laboratory Supervisor
Pace Analytical, 3M Food Safety Department
04.2017 - 11.2018Read More
Quality Assurance and Manufacturing Microbiologist
Pace Analytical, 3M Food Safety Department
01.2017 - 11.2018Read More
Research and Development Microbiologist
Pace Analytical, 3M Food Safety Department
12.2014 - 12.2017Read More
Minnesota State University, Mankato
Bachelor of Science (B.S.) from Biology, Microbiology