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Senior Quality Assurance Specialist
I strengthen FDA-regulated quality systems, batch release, investigations, and compliance across pharmaceutical and nutraceutical manufacturing.
United StatesSenior Quality Assurance Specialist at Bristol Myers Squibb
Provide quality guidance to ensure safety, identity, and purity of products. Oversee quality management systems, conduct audits, and support compliance with GMPs.
Quality AssuranceGMPAuditRoot Cause AnalysisCAPAChange ControlSOPsCompliance
Provide quality guidance to ensure safety, quality, identity, potency, and purity of products. Oversee Quality Management System including change controls, deviations, complaints, and CAPAs, and conduct root cause analysis investigations.
Quality Management SystemsGMPChange ControlDeviation ManagementCAPARoot Cause AnalysisBatch Record ReviewSOPsVendor ManagementTrainingProcess Improvement
Generated and updated documents within document management system to ensure compliance. Improved data accuracy by communicating with departments and translating data into LIMS.
Data EntryDocument ManagementLIMSProcess Improvement
Ensured thorough and timely investigations into deviations and change controls. Issued batch records and associated forms to production as needed for accurate documentation.
Quality AssuranceDeviation ManagementChange ControlBatch RecordsDocumentationSOPsQMSQuality Management SystemsInvestigationProcess ValidationTraining
Researched raw materials and maintained technical specifications. Performed testing of raw materials and finished products using HPLC/UPLC machines.
UPLCDocumentationResearchTesting
Ensured compliance with regulatory standards and engaged in Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). Utilized HPLC and GC-MS techniques for precise analytical measurements and quality control, and assisted in training personnel.
HPLCGC MSGLPGMPQuality ControlAnalytical ChemistryTraining
Affirmed compliance with regulatory standards while engaging in GLP and GMP. Utilized HPLC and GC-MS techniques for precise analytical measurements and quality control.
GC MSGLPGMPQuality ControlTrainingBatch Correction
Bachelor of Science in Biology from Arizona State University West, completed in 2016.
Bachelor of Science in Biology from Arizona State University West, completed in 2016.
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