Faye Fulton
Smyrna,DE
Summary
Detailed oriented and customer focused Quality Assurance Professional with dedication to quality and accuracy. Experienced in the Pharmaceutical, Biopharmaceutical and Insurance industries. Familiar with handling multiple projects in highly competitive environments. Solid interpersonal and collaboration skills.
Overview
37
37
years of professional experience
Work History
Pharmaceutical Quality Assurance Professional
American Red Cross And Various
09.1995 - 05.2023
- Performed QA review of executed manufacturing records, QC test and environmental monitoring data, against pre-established specifications, internal standard operating procedures (SOPs), and FDA regulations. Approved and released final products.
- Reviewed deviation and non-conformance reports and assisted in closure of investigations. Reviewed change controls, equipment qualification (IOPQs), and method validations to identify potential quality issues.
- Established effective communication channels between QA and other departments, promoting collaboration and a shared commitment to quality.
- Conducted regular internal process assessments and external audits ensuring compliance with established procedures and regulations. Enhanced customer satisfaction with thorough inspections and prompt resolution of reported issues. Collaborated with quality team to implement corrective actions.
Senior Underwriter
Colonial Penn Insurance Company
12.1985 - 09.1992
- Evaluated homeowner and umbrella liability insurance applications to make accurate decisions by accounting for risk, hazards and exposure. Applied knowledge of underwriting guidelines to maintain compliance with applicable regulations and company standards.
- Supported review, acceptance or denial of new or renewal business after carefully reviewing all information including claims reports from loss control specialist to determine risk.
- Participated in industry conferences and seminars to stay informed about the latest trends, regulatory changes, and best practices in underwriting.
- Studied insurance industry changes, remaining up-to-date with latest trends and protocols.
Education
Bachelor of Science - Operations Management
Penn State University
State College, PAAssociate of Science - Chemical Technology
Community College of Philadelphia
Philadelphia, PASkills
- Manufacturing Process Oversight
- Executed Batch Record, QC Data review
- Finished Product Release
- Deviation and CAPA reviews
- Non-Conformance and Change Control Review
- Equipment (IOPQ) and Method Validation review
Timeline
Pharmaceutical Quality Assurance Professional
American Red Cross And Various
09.1995 - 05.2023
Senior Underwriter
Colonial Penn Insurance Company
12.1985 - 09.1992
Bachelor of Science - Operations Management
Penn State University
Associate of Science - Chemical Technology
Community College of Philadelphia
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