Quality Control Analyst with 3.5 years of experience in regulated manufacturing environments, specializing in microbiological testing, deviation investigations, CAPA management, and GMP-compliant quality systems. Proven ability to analyze quality trends, support product release, and maintain rigorous documentation standards in FDA-regulated industries. Adept at cross-functional collaboration with manufacturing, quality assurance, and external partners to ensure product safety, compliance, and continuous improvement. Seeking to apply strong analytical and quality systems expertise within the food and beverage industry.
Overview
4
4
years of professional experience
Work History
Quality Control Microbiology Analyst
Minaris Advanced Therapies
Allendale, NJ
09.2023 - Current
Conduct routine and non-routine microbiological testing, including environmental monitoring (non viable, viable, surface) in ISO 5/7/8 cleanrooms.
Analyzed environmental and in-process data, identify trends, and generate quality reports to support investigations and continuous improvement initiatives.
Lead and support deviation investigations, root cause analysis, and implementation of corrective and preventative actions (CAPAs).
Review batch records and supporting documentation to support product release decisions and ensure compliance with FDA regulatory expectations.
Participate in quality system maintenance, including SOP review and revision to improve clarity, compliance, and operational efficiency.
Collaborate cross-functionally with Manufacturing, Quality Assurance, and external clients to resolve quality issues and maintain compliance.
Cell Therapy Manufacturing Associate
Bristol Myers Squibb
Summit, NJ
06.2022 - 05.2023
Support aseptic manufacturing operations under cGMP guidelines in ISO 5/7 environments.
Executed sterile techniques and environmental monitoring to ensure product safety and contamination control.
Maintained accurate batch documentation in compliance with GDP requirements and supported batch record review.
Maintained accurate batch documentation in compliance with GDP requirements and supported batch record review.
Partnered with Quality and Manufacturing teams to ensure adherence to controlled processes and quality standards.
Education
Master of Business Administration - Pharmaceutical Management
Fairleigh Dickinson University
Madison, NJ
01.2027
Bachelor of Science - Biology
Montclair State University
Montclair, NJ
05-2022
Skills
Quality Systems Management (CAPA, Deviations, Change Control)
Operational, Facilities and Maintenance Engineer at Granules Consumer HealthcareOperational, Facilities and Maintenance Engineer at Granules Consumer Healthcare