Quality Analyst with expertise in process improvement, data analysis, and quality audits. Proficient in CGMP methodologies, FDA regulations, and ISO standards. Demonstrated success in enhancing product quality and implementing compliance strategies.
Overview
8
8
years of professional experience
Work History
Quality Assurance Analys
New Jersey Laboratories
New Brunswick, New Jersey
07.2022 - Current
Implemented corrective actions for non-conforming products effectively.
Trained staff on quality standards and inspection procedures consistently.
Analyzed data to identify trends and areas for improvement in processes.
Assisted in audits to ensure compliance with industry regulations and standards.
Reviewed documentation related to changes in product design, process, raw materials for potential impact on quality assurance requirements.
Compiled reports summarizing findings from QA inspections, tests, and reviews for management review.
Documented non-conformance issues according to company policies and procedures.
Collaborated with management to discuss effective plans for resolving major quality problems.
Assisted in the development and validation of testing methods for quality control purposes.
Led internal audits to identify areas for improvement and ensure adherence to quality management systems.
Conducted risk assessments to identify potential quality issues and developed mitigation strategies.
Participated in external audits and regulatory inspections, providing necessary documentation and support.
Served as the primary point of contact for all stability-related inquiries from clients, delivering prompt and accurate responses.
Functioned as the documentation subject matter expert (SME), developing a comprehensive Good Manufacturing Practices (GMP) training course for all employees.
Reviewed and approved the method verification and validation of USP methods performed in the chemistry laboratory, confirming adherence to established parameters.
Conducted routine chemistry notebook reviews encompassing HPLC, GC, ICP-MS, wet chemistry, protein, conductivity, amino acid analyses, and ninhydrin positive substances by post-column derivatization, adhering to internal SOPs and other compendial methods.
Quality Control Analyst
AMES
Plainfield, New Jersey
05.2021 - 06.2022
Analyzed test results to ensure compliance with quality standards.
Conducted quality inspections on raw materials and finished products.
Developed and maintained standard operating procedures for laboratory processes.
Utilized chromatography and spectroscopy techniques for sample analysis.
Performed laboratory analysis of raw materials, in-process and finished products to ensure compliance with quality specifications.
Analyzed samples submitted for testing and reported results.
Created and documented test procedures and updated or expanded existing procedures.
Analytical Chemist
Sarchem Laboratories
Farmingdale, NJ
06.2019 - 05.2021
Set up and conduct chemical experiments, tests, and analyses, using techniques such as chromatography, spectroscopy, physical or chemical separation techniques, or microscopy.
Conduct chemical or physical laboratory tests to assist scientists in making qualitative or quantitative analyses of solids, liquids, or gaseous materials.
Prepare chemical solutions for products or processes, following standardized formulas, or create experimental formulas.
Monitor product quality to ensure compliance with standards and specifications.
Compile and interpret the results of tests and analyses.
Research Coordinator - Corporate Engagement Lead
JERSEY STEM
Summit, NJ
01.2019 - 01.2020
Supervised a team of 20 interns who researched on companies that Jersey STEM could potentially partner with.
Ensured smooth and efficient day-to-day operation of research and data collection activities.
Project & Engineering Management Intern
Tullow Oil
Accra, Accra
05.2017 - 09.2017
Evaluated chemical equipment and processes to identify ways to optimize performance.
Simulated reservoir performance for different recovery techniques, using computer models.
Monitored production rates, and planned rework processes to improve production.
Assisted engineering and other personnel to solve operating problems.
Wrote technical reports for engineering and management personnel.
Assisted in coordinating root cause analysis (RCA) for incidents.