Manufacturing Quality Analyst

• Jan 2023 - Present

Quality Control Analyst

• Jun 2020 - Jan 2023

▪ Develop standard operating procedures (SOPs) to streamline quality control process, onboarding, and operations ▪ Develop test plans and scripts to confirm accuracy of requirements and testing and write quality records (Deviations, CAPA, Change Control) and test methods ▪ Collaborate with chemists and clinical teams to conduct microbiological and chemical testing in support of manufacturing, raw materials, environmental systems ▪ Develop standard operating procedures (SOPs) to streamline quality control process, onboarding, and operations ▪ Develop test plans and scripts to confirm accuracy of requirements and testing and write quality records (Deviations, CAPA, Change Control) and test methods ▪ Collaborate with chemists and clinical teams to conduct microbiological and chemical testing in support of manufacturing, raw materials, environmental systems

Regulatory Affairs Associate (specifications specialist)

• Jun 2021 - May 2022

▪ Led the review of regulatory requirements and organizational standing and developed standard operating procedures (SOPs) to ensure department compliance with regulatory and local, state, and federal guidelines, such as HIPAA, FDA, and overall liability ▪ Managed and reviewed the routing of all specifications including finished goods, intermediate goods, ingredients, packaging materials, and formulas in conjunction with the Master Data and ERP specifications system with a 100% delivery rate ▪ Collaborated with cross-functional teams such as commercialization, R&D Product Developers, and Plant Quality Assurance throughout product lifecycle providing regulatory strategy and direction to ensure effective productive development ▪ Managed process improvement strategies, developed progress trackers, and conducted internal audits to ensure compliance and assess regulatory impact of product changes, reducing the product registration timeline by 2 months Show less

Quality analyst / Chemist

• Jun 2019 - May 2021

▪ Performed research in collaboration R&D, engineering, formulations, and manufacturing to devise methods for improving product quality and assurance methods ▪ Maintained quality management system and SOPs to ensure internal processes adhered to regulatory requirements ▪ Managed document repository and reviewed compliance for documentation for records, label creation, and inventory control ▪ Performed analytical testing of prepared solutions, reporting of inspection, and test data to ensure conformance to specifications with a 100% requirements compliance rate Show less

Home Health Aide

• Oct 2017 - May 2019

▪ Developed onboarding training to increase knowledge transfer and patient intake metrics leading to 35% increase in one year ▪ Provided excellent patient care with individualized care, family communication, operations management, and record keeping ▪ Administered prescribed medication to 15+ residents daily to ensure they followed the doctor’s medical advice ▪ Developed onboarding training to increase knowledge transfer and patient intake metrics leading to 35% increase in one year ▪ Provided excellent patient care with individualized care, family communication, operations management, and record keeping ▪ Administered prescribed medication to 15+ residents daily to ensure they followed the doctor’s medical advice