Michelle Fields
Frederick
Summary
Detail-focused professional, offering expertise in good documentation practices, document management and quality customer service. Adept at quickly learning new technologies and processes for driving success. Proven track record of commendably using successful methods to cut costs and a superlative work ethic.
Overview
16
16
years of professional experience
Work History
REGULATORY DOCUMENTATION SPECIALIST
Bayer CropScience Ltd
05.2022 - 06.2024
- Improved document organization by implementing a comprehensive filing system for easy access and retrieval.
- Conducted regular audits of existing documentation to identify gaps or outdated information, keeping all materials current and relevant.
- Maintained organized and efficient document flows by using excellent planning and multitasking skills.
- Identified areas of weakness and recommended or implemented process improvements.
QUALITY DOCUMENTATION SPECIALIST
IZI Medical Products
11.2018 - 01.2020
- Perform comprehensive batch record review to ensure good documentation practices and prevention of quality events and deviations
- Developed improvement, corrective, and preventive action plans to align operations with requirements
- Coordinated with subject matter experts to gather accurate information for document creation or revisions
- Supported audit preparation efforts with thorough document organization and management practices.
PRODUCTION QUALITY INSPECTOR
United States Pharmacopeia
08.2014 - 11.2018
- Performed frequent visual inspections to root out tolerance and compliance issues.
- Implemented corrective actions for non-conforming products, reducing the risk of customer dissatisfaction or returns
- Assisted in training new quality inspectors; sharing knowledge of best practices and industry standards
- Collaborated with manufacturing team to ensure consistent quality standards across all products.
PRODUCTION MANUFACTURING ASSOCIATE III
Eisai Pharmaceuticals
08.2008 - 07.2014
- Enhanced product quality by meticulously adhering to standard operating procedures.
- Monitored and troubleshoot machinery to ensure optimal performance, reducing downtime.
- Exceeded daily production targets with consistent attention to detail and commitment to meeting deadlines.
- Maintained accurate production records for analysis purposes, ensuring traceability of products throughout the entire manufacturing process.
Education
Bachelor of Arts - Business Administration
Strayer University
White Marsh, MD12.2015
Graduate Certificate - Allied Human Services
Community College of Baltimore
Baltimore, MD06.2005
Skills
- Documentation Management
- Proficient with Microsoft Programs
- Quality assurance
- Regulatory Submission Support
- Strong Team Player
- Effective Time Management
- Exceptional Attention to Detail
- Organizational Skills
- Continuous Improvement
- Corrective and Preventive Actions
Awards
06/01/14, Alpha Sigma Lambda, The Honor Society
Timeline
REGULATORY DOCUMENTATION SPECIALIST
Bayer CropScience Ltd
05.2022 - 06.2024
QUALITY DOCUMENTATION SPECIALIST
IZI Medical Products
11.2018 - 01.2020
PRODUCTION QUALITY INSPECTOR
United States Pharmacopeia
08.2014 - 11.2018
PRODUCTION MANUFACTURING ASSOCIATE III
Eisai Pharmaceuticals
08.2008 - 07.2014
Bachelor of Arts - Business Administration
Strayer University
Graduate Certificate - Allied Human Services
Community College of Baltimore
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