Experience

Jost Chemical

• United States
• Chemical Manufacturing
• 100 - 200 Employee

• Quality Assurance Specialist

  • Oct 2022 - Present

  Validation, Equipment Qualification, Auditing, Change Control Validation, Equipment Qualification, Auditing, Change Control



Averhealth

• United States
• Mental Health Care
• 1 - 100 Employee

• Analytical Chemist

  • Apr 2022 - Present

  Chromatography, LCMS, GCMS Chromatography, LCMS, GCMS



Luxco, Inc.

• United States
• Wine & Spirits
• 100 - 200 Employee

• Quality Assurance Laboratory Technician

  • Nov 2019 - Apr 2022

  Major Responsibilities: ▪ Check the Proof (Alcohol %), Specific gravity, Solid content, pH, Turbidity, citric acid content, UV-Vis of formulas and any receiving sample. Give adjustment if required. ▪ Do required testing for any receiving color or flavor. ▪ Batch startup release and test one line sample from each production batch. ▪ Prepare sample for GCMS & Run sequence in GCMS ▪ Do line inspection in manufacturing floor and report any non-compliance. ▪ Check RO water… Show more Major Responsibilities: ▪ Check the Proof (Alcohol %), Specific gravity, Solid content, pH, Turbidity, citric acid content, UV-Vis of formulas and any receiving sample. Give adjustment if required. ▪ Do required testing for any receiving color or flavor. ▪ Batch startup release and test one line sample from each production batch. ▪ Prepare sample for GCMS & Run sequence in GCMS ▪ Do line inspection in manufacturing floor and report any non-compliance. ▪ Check RO water system. ▪ Do AQL on export finish good. ▪ Check the fill height and torques of the bottles. ▪ Microbial swap testing for low proof product. ▪ Record all data in QUEST (Luxco data management software) Show less Major Responsibilities: ▪ Check the Proof (Alcohol %), Specific gravity, Solid content, pH, Turbidity, citric acid content, UV-Vis of formulas and any receiving sample. Give adjustment if required. ▪ Do required testing for any receiving color or flavor. ▪ Batch startup release and test one line sample from each production batch. ▪ Prepare sample for GCMS & Run sequence in GCMS ▪ Do line inspection in manufacturing floor and report any non-compliance. ▪ Check RO water… Show more Major Responsibilities: ▪ Check the Proof (Alcohol %), Specific gravity, Solid content, pH, Turbidity, citric acid content, UV-Vis of formulas and any receiving sample. Give adjustment if required. ▪ Do required testing for any receiving color or flavor. ▪ Batch startup release and test one line sample from each production batch. ▪ Prepare sample for GCMS & Run sequence in GCMS ▪ Do line inspection in manufacturing floor and report any non-compliance. ▪ Check RO water system. ▪ Do AQL on export finish good. ▪ Check the fill height and torques of the bottles. ▪ Microbial swap testing for low proof product. ▪ Record all data in QUEST (Luxco data management software) Show less



Express Scripts

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Quality Assurance Inspector

  • Oct 2017 - Jun 2018

  Major responsibilities: ▪ Standard Work Audit of technicians on their daily job. ▪ Standard Work Audit of pharmacists on their daily job ▪ Pack Auditing ▪ Monthly Calibration of Kirby/Eyecon counting tools. ▪ Monthly Calibration of weighing scales. ▪ Weight fails manifestation. ▪ Canister Lock audit, Shelf audit. ▪ Preparation of SOP. ▪ QA training. ▪ Preparation of Standard Work Audit. ▪ Report any Non-Compliant issue through incident tracker… Show more Major responsibilities: ▪ Standard Work Audit of technicians on their daily job. ▪ Standard Work Audit of pharmacists on their daily job ▪ Pack Auditing ▪ Monthly Calibration of Kirby/Eyecon counting tools. ▪ Monthly Calibration of weighing scales. ▪ Weight fails manifestation. ▪ Canister Lock audit, Shelf audit. ▪ Preparation of SOP. ▪ QA training. ▪ Preparation of Standard Work Audit. ▪ Report any Non-Compliant issue through incident tracker. ▪ Record and follow up Pharmacy Recalls & Quality Alert. Show less Major responsibilities: ▪ Standard Work Audit of technicians on their daily job. ▪ Standard Work Audit of pharmacists on their daily job ▪ Pack Auditing ▪ Monthly Calibration of Kirby/Eyecon counting tools. ▪ Monthly Calibration of weighing scales. ▪ Weight fails manifestation. ▪ Canister Lock audit, Shelf audit. ▪ Preparation of SOP. ▪ QA training. ▪ Preparation of Standard Work Audit. ▪ Report any Non-Compliant issue through incident tracker… Show more Major responsibilities: ▪ Standard Work Audit of technicians on their daily job. ▪ Standard Work Audit of pharmacists on their daily job ▪ Pack Auditing ▪ Monthly Calibration of Kirby/Eyecon counting tools. ▪ Monthly Calibration of weighing scales. ▪ Weight fails manifestation. ▪ Canister Lock audit, Shelf audit. ▪ Preparation of SOP. ▪ QA training. ▪ Preparation of Standard Work Audit. ▪ Report any Non-Compliant issue through incident tracker. ▪ Record and follow up Pharmacy Recalls & Quality Alert. Show less



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Assurance Officer

  • May 2013 - Jan 2017

  I worked as In Process Quality Assurance Officer. My primary role was to ensure compliance in drug manufacturing & packaging floor & testing of the physical parameter of drug products against predefined specifications. Besides I was responsible for preparing Annual Product Quality Review, Deviation Investigation through Trackwise, Equipment Qualification & final batch release. Overview of work experience 1. Physical testing of the intermediate drug product using different types… Show more I worked as In Process Quality Assurance Officer. My primary role was to ensure compliance in drug manufacturing & packaging floor & testing of the physical parameter of drug products against predefined specifications. Besides I was responsible for preparing Annual Product Quality Review, Deviation Investigation through Trackwise, Equipment Qualification & final batch release. Overview of work experience 1. Physical testing of the intermediate drug product using different types of equipment and report any deviation (SQC balance, Hardness Tester, Moisture analyzer, Disintegration tester, Mean weight testing, Length/Width/Thickness testing, Leak tester, Friability tester, etc.) 2. Prepare sample for HPLC and run for Identification and Quantification of finished good. 3. Water Content by Karl-Fisher method Spectroscopy by UV-Vis. 4. Inspection of Incoming materials against CoA, Batch record, Labels and Quantity. 5. SOP (Standard Operating Procedure) preparation. 6. New equipment Installation, Calibration, Qualification and preparation of General Method (Operating Procedure). 7. Ensure Data Integrity and cGMP. 8. Preparation of Annual Product Quality Review 9. Ensure compliance in manufacturing & packaging floor. 10. Batch data analysis & trending with MINITAB statistical software. 11. EU and Novartis internal audit face. 12. Expertise in SAP system 13. Deviation Investigation & Handling of Market Complaint 14. Batch Record review and report any non-compliance. 15. Logistics support for IPQA lab & purchasing of new equipment. 16. Mock Audit in manufacturing and packaging floor. 17. Preparation & Maintenance of logbook. 18. Ensure sampling at different stages for laboratory purpose & perform AQL if required. 19. Ensure Transfer Certificate before packaging 20. Line clearance before any Manufacturing or packaging process. 21. Report any near miss from HSE (Health, Safety & Environment) point of view. Show less I worked as In Process Quality Assurance Officer. My primary role was to ensure compliance in drug manufacturing & packaging floor & testing of the physical parameter of drug products against predefined specifications. Besides I was responsible for preparing Annual Product Quality Review, Deviation Investigation through Trackwise, Equipment Qualification & final batch release. Overview of work experience 1. Physical testing of the intermediate drug product using different types… Show more I worked as In Process Quality Assurance Officer. My primary role was to ensure compliance in drug manufacturing & packaging floor & testing of the physical parameter of drug products against predefined specifications. Besides I was responsible for preparing Annual Product Quality Review, Deviation Investigation through Trackwise, Equipment Qualification & final batch release. Overview of work experience 1. Physical testing of the intermediate drug product using different types of equipment and report any deviation (SQC balance, Hardness Tester, Moisture analyzer, Disintegration tester, Mean weight testing, Length/Width/Thickness testing, Leak tester, Friability tester, etc.) 2. Prepare sample for HPLC and run for Identification and Quantification of finished good. 3. Water Content by Karl-Fisher method Spectroscopy by UV-Vis. 4. Inspection of Incoming materials against CoA, Batch record, Labels and Quantity. 5. SOP (Standard Operating Procedure) preparation. 6. New equipment Installation, Calibration, Qualification and preparation of General Method (Operating Procedure). 7. Ensure Data Integrity and cGMP. 8. Preparation of Annual Product Quality Review 9. Ensure compliance in manufacturing & packaging floor. 10. Batch data analysis & trending with MINITAB statistical software. 11. EU and Novartis internal audit face. 12. Expertise in SAP system 13. Deviation Investigation & Handling of Market Complaint 14. Batch Record review and report any non-compliance. 15. Logistics support for IPQA lab & purchasing of new equipment. 16. Mock Audit in manufacturing and packaging floor. 17. Preparation & Maintenance of logbook. 18. Ensure sampling at different stages for laboratory purpose & perform AQL if required. 19. Ensure Transfer Certificate before packaging 20. Line clearance before any Manufacturing or packaging process. 21. Report any near miss from HSE (Health, Safety & Environment) point of view. Show less