Michelle Fields
Frederick,MD
Summary
Resourceful Specialist 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
10
10
years of professional experience
Work History
Regulatory Documentation Specialist
BAYER
05.2022 - 06.2024
- Manage regulatory databases, systems and applications to ensure all systems are accurate and up-to-date
- File, review, edit and format documents accurately; identifying errors, inconsistencies and/or noncompliance issues.
- Followed all company policies and procedures to deliver quality work.
- Enhanced customer satisfaction with timely and accurate issue resolution.
- Gathered, organized and input information into digital database.
- Collected, arranged, and input information into database system.
Remote Online ESL Teacher
EDUCATION FIRST
10.2019 - 04.2022
- Communicated with students using Zoom and online learning platforms, webcams and headphones.
- Developed strong rapport with parents by maintaining open lines of communication regarding their child''s academic progress, challenges, and successes.
- Increased student motivation and participation by implementing a rewards system based on individual progress and effort.
- Identified and addressed problems with course content or technology.
- Educated students in basics of English grammar and conversational speaking.
- Created and delivered engaging lesson plans to accommodate different learning styles.
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
- Supported continuous improvement initiatives with regular audits and assessments of existing documentation processes.
- Streamlined document control processes, resulting in increased efficiency and reduced errors.
- Performed root cause analysis on recurring documentation issues, leading to effective solutions implementation.
- Coordinated with subject matter experts to gather accurate information for document creation or revisions.
- Maintained version control systems, ensuring access to the most current versions of each file at all times.
- Established strong relationships with internal clients to better understand their documentation needs.
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.
- Discarded and rejected products, materials and equipment not conforming with specifications.
- Assisted in training new Quality Inspectors, sharing knowledge of best practices and industry standards.
- Inspected products meticulously according to manufacturing specifications.
- Inspected incoming and outgoing materials for accuracy and quality.
- Utilized gauges, tools and equipment to complete in-depth assessments.
Education
120-Hour TESOL Certificate -
International Open Academy
07.2019
Bachelor of Arts - Business Administration
Strayer University
White Marsh, MD12.2015
No Degree - Allied Human Services (Certificate)
Community College of Baltimore
Baltimore, MD06.2005
Skills
- Proficient with Microsoft Programs
- Natural Leader
- Calm Under Pressure
- Strong Team Player
- Great Time Management
- Exceptional Attention to Detail
- Documentation Management
- Quality Assurance
- Time Management
- Attention to Detail
- Organizational Skills
- Continuous Improvement
Awards
06/01/14, Alpha Sigma Lambda, The Honor Society
Timeline
Regulatory Documentation Specialist
BAYER
05.2022 - 06.2024
Remote Online ESL Teacher
EDUCATION FIRST
10.2019 - 04.2022
Quality Documentation Specialist
IZI Medical Products
11.2018 - 01.2020
Production Quality Inspector
United States Pharmacopeia
08.2014 - 11.2018
120-Hour TESOL Certificate -
International Open Academy
Bachelor of Arts - Business Administration
Strayer University
No Degree - Allied Human Services (Certificate)
Community College of Baltimore
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