Experience

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  Sigma-aldrich

  Jan 2014 - Mar 2015

  Chemical technician

  • Lab tested all raw materials for quality and product verification• Utilized specialized material testing devices such as FTNIR, gas chromatography, Loss on drying ovens, Karl Fischer, density, pH meters, and flash point to maintain highest quality standards• Centrifuge operation with strict adherence to SOP to ensure desired solvent extraction is achieved• Strict adherence to batch process with diligent monitoring and contemporaneous record keeping• Clean, sanitize, and purge tanks and process lines/hoses with strict adherence to C.I.P. and process SOPs• Verify and validate adherence to strict cleaning procedures to prevent cross contamination• Utilized Solvent Tempering Unit (specialized solvent heat exchanger) within seasonal necessity• Proficient use of various programs and equipment integral to the processing and production operations including deionizing towers, vacuum and atmospheric reactors, solvent tempering units, compressed nitrogen towers, and control room monitoring tools, ensuring the efficient and accurate execution of tasks while maintaining stringing quality and safety standards throughout the production process. • Successfully validated purity of all raw materials prior to use in individual batches of products, ensuring compliance with strict quality control standards.• Conducted precise pH adjustments and molarity calculations to meet exact specifications for research and productions needs.• Maintained all GMP documentation of all compounding processes, utilizing GDP standards and contributing to traceability and regulatory compliance.• Ensured all equipment was calibrated, cleaned, and maintained to uphold the integrity of the compounding process. Show less

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  Pfizer

  Apr 2015 - Mar 2018

  Aseptic quality specialist

  • Managed aseptic manufacturing and clean room environments, ensuring proper procedures for auto-injectable medication by ensuring compliance with cGMP standards, validated batch records, and inspected life-saving products for defects.• Executed process improvements and adhered to safety, documentation protocols, and FDA standards for product quality and consistency in an aseptic environment.• Trained and supervised new quality department employees while maintaining contemporaneous documentation and proper labeling control. Reviewed and utilized up-to-date SOPs, followed batch records, and maintained proper label control, verification, and disposal processes Show less

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  Parcus medical

  May 2019 - Oct 2019

  Quality inspector

  •Adhere to quality work instructions for surgical soft tissue repair devices•Review for non-conforming processes that would affect quality of the devices•Determine and recommend changes to quality protocol in collaboration with process engineering

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  Saint-gobain performance plastics

  Oct 2019 - May 2021

  Quality specialist

  • Provided detailed training and guidance to direct report team members on quality assurance processes to maintain high standards across operations.• Successfully led root cause analysis for reported defects, implementing corrective actions to prevent reoccurrence.• Reviewed and updated quality control protocols to align with the latest industry regulations and best practices.• Comprehensive training across all facets of quality assurance, encompassing incoming, in-process, and outbound component and finished products to ensure adherence to the highest standards of quality control and operational excellence.• Conducted thorough quality reviews of records; external supplier COCs and COAs, internal compounding records to generate COC and COA records for internal and external customers, ensuring compliance with regulatory standards and company specifications. Show less

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  Sleep international

  May 2021 - Aug 2021

  Quality and safety manager

  • Implemented new quality control checklists and SOPs in 3 languages to accommodate the diversity of the workforce, reducing defect rates and led training sessions for staff on updated safety protocols, improving adherence across all departments. Conducted thorough inspections of production lines and finished products to ensure all finished goods met established quality and safety standards. Address and resolved staff feedback related to safety concerns, enhabcing overall satisfaction for the work environment• Conducted thorugh inspections of production lines and finished products to ensure all finished goods met established quality and safety standards.• Collaborated with R&D team to test and certify new fire-resistant materials for compliance with safety regulations. Show less

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  Valpak

  Feb 2022 - Jan 2023

  Quality specialist

  • Successfully resolution of customer inquiries and complaints within 3 business days, ensuring high levels of customer satisfaction.• Conducted thorough quality control checks on 100+ products and processes, identifying and addressing potential issues before production and distribution supporting consistent product excellence and operational efficiency.• Collaborated with cross-functional teams to streamline support processes, reducing response times and ensuring return to production in a timely manner.• Developed and implemented training programs conducting hands-on demonstrations, and providing clear guidance to enhance understanding and adherence to quality benchmarks and responsible for delivering comprehensive training to production workers on current and updated quality standards, ensuring they were well-versed in latest protocols and procedures. Show less

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  Pai pharma

  Oct 2022 - now

  Product quality engineer

  • Solely responsible for managing the end-to-end process of Customer Complaints. Cross-functioning team member for Statistical Engineering, Deviations, CAPA, and Change Control Teams.• Point of Contact (POC) for All law enforcement agencies for counterfeit and/or diversion-related inquiries and investigations. Ensure timely and appropriate reporting of counterfeit and diversion incidents to relevant authorities, and prepare court admissible documents for the relevant authority.• Primary contact for all Notice of Events (NOEs), assessing and classifying product impact, ensuring prompt resolution and escalation when necessary. • Conduct root cause analysis for complaints, deviations, and CAPAs, ensuring the implementation of effective corrective and preventive actions to mitigate risks and prevent recurrence and collaborate with cross-functional teams to identify and implement corrective/preventive actions (CAPAs) designed to address quality deficiencies and ensure compliance with regulatory standards.• Train and support stakeholders on the specialized Quality Management Systems and statistical tools TrackWise, ZEN QMS, SAP, SharePoint, and Blue Mountain for effective investigations.• Identify trends in Complaint, Deviation, and CAPA data to ensure compliance with federal regulations, recommending process improvements or preventive actions based on findings.• Author and review QA-related documents, including deviations, OOS investigations, product quality complaints, CAPAs, Regulatory Reports, and change controls, ensuring accurate execution in compliance with regulatory requirements.• Review, approve, and assist with the development of technical documentation, including SOPs, validation documents, and equipment qualifications, to support operations and ensure compliance with SOPs, cGMPs, and FDA requirements. Show less