Quality Assurance/Regulatory Affairs Specialist

• Jan 2022 - Present

SCIENTIST II

• Apr 2016 - Jan 2022

Project-manage all aspects of Biological Indicator medical device utilizing bacterial endospores to indicate sterility assurance in healthcare setting. Manage biological technologists, technicians, and other scientists through project outline, media formulation, method creation, personnel training, management updates and reporting, quality assurance, test and data confirmation, FDA submission activities, and troubleshooting. Represent company at conferences. Review validation test data to… Show more Project-manage all aspects of Biological Indicator medical device utilizing bacterial endospores to indicate sterility assurance in healthcare setting. Manage biological technologists, technicians, and other scientists through project outline, media formulation, method creation, personnel training, management updates and reporting, quality assurance, test and data confirmation, FDA submission activities, and troubleshooting. Represent company at conferences. Review validation test data to establish systems/process validation criteria and note root causes of production problems. Solve testing issues by adjusting testing methods, objectives and standards. Audit validation/performance qualification protocols to comply with regulatory requirements. Train equipment operators and other staff on validation processes and standard operating procedures. • Designed system decreasing cost per lot from $950 to $52 and labor commitment from 34.5 hours to 2 with final product available in 24 hours versus several weeks and reduced incubation time of 5 minutes, 4 times faster than existing device. Show less Project-manage all aspects of Biological Indicator medical device utilizing bacterial endospores to indicate sterility assurance in healthcare setting. Manage biological technologists, technicians, and other scientists through project outline, media formulation, method creation, personnel training, management updates and reporting, quality assurance, test and data confirmation, FDA submission activities, and troubleshooting. Represent company at conferences. Review validation test data to… Show more Project-manage all aspects of Biological Indicator medical device utilizing bacterial endospores to indicate sterility assurance in healthcare setting. Manage biological technologists, technicians, and other scientists through project outline, media formulation, method creation, personnel training, management updates and reporting, quality assurance, test and data confirmation, FDA submission activities, and troubleshooting. Represent company at conferences. Review validation test data to establish systems/process validation criteria and note root causes of production problems. Solve testing issues by adjusting testing methods, objectives and standards. Audit validation/performance qualification protocols to comply with regulatory requirements. Train equipment operators and other staff on validation processes and standard operating procedures. • Designed system decreasing cost per lot from $950 to $52 and labor commitment from 34.5 hours to 2 with final product available in 24 hours versus several weeks and reduced incubation time of 5 minutes, 4 times faster than existing device. Show less

Research Assistant

• Jan 2014 - Apr 2016

Prepared and delivered basic genomic and biological research related to regulating gene expression, protein interactions, metabolic networks, and nucleic acid of protein complexes. Studied scientific literature to choose and revise methods and processes to achieve genetic research objectives. Recorded research methods, procedures, and results in laboratory notebooks. • Obtained deoxyribonucleic acid (DNA) and conducted diagnostic tests involving processes including gel electrophoresis… Show more Prepared and delivered basic genomic and biological research related to regulating gene expression, protein interactions, metabolic networks, and nucleic acid of protein complexes. Studied scientific literature to choose and revise methods and processes to achieve genetic research objectives. Recorded research methods, procedures, and results in laboratory notebooks. • Obtained deoxyribonucleic acid (DNA) and conducted diagnostic tests involving processes including gel electrophoresis, Southern blot analysis, and polymerase chain reaction analysis. • Authored and presented results of experimental findings at professional conferences and in scientific journals.

Graduate Research Assistant

• May 2014 - Mar 2016

CONTRACT LAB ASSOCIATE

• Aug 2012 - Jan 2014

Conducted basic and non-basic analyses of in-process/raw materials, environmental samples, completed goods, and stability samples. Secured and analyzed laboratory test data. Documented support testing procedures including data capture forms, equipment logbooks, and inventory forms. Reviewed analytical methods and protocols and recommended quality improvements. Interpreted and compared test results to established specifications and control limits and suggested better methods to release data… Show more Conducted basic and non-basic analyses of in-process/raw materials, environmental samples, completed goods, and stability samples. Secured and analyzed laboratory test data. Documented support testing procedures including data capture forms, equipment logbooks, and inventory forms. Reviewed analytical methods and protocols and recommended quality improvements. Interpreted and compared test results to established specifications and control limits and suggested better methods to release data. Studied and reported questionable test results. · Tracked testing processes to guarantee performance matched item specifications, standard test methods, and protocols. · Attended out-of-specification and failure investigations and internal reviews and audits and proposed corrective actions. Show less Conducted basic and non-basic analyses of in-process/raw materials, environmental samples, completed goods, and stability samples. Secured and analyzed laboratory test data. Documented support testing procedures including data capture forms, equipment logbooks, and inventory forms. Reviewed analytical methods and protocols and recommended quality improvements. Interpreted and compared test results to established specifications and control limits and suggested better methods to release data… Show more Conducted basic and non-basic analyses of in-process/raw materials, environmental samples, completed goods, and stability samples. Secured and analyzed laboratory test data. Documented support testing procedures including data capture forms, equipment logbooks, and inventory forms. Reviewed analytical methods and protocols and recommended quality improvements. Interpreted and compared test results to established specifications and control limits and suggested better methods to release data. Studied and reported questionable test results. · Tracked testing processes to guarantee performance matched item specifications, standard test methods, and protocols. · Attended out-of-specification and failure investigations and internal reviews and audits and proposed corrective actions. Show less

Automotive Manager

• 1998 - 2008

Performed all aspects of team management and scheduling, diagnostic procedures and repairs, and automotive customization. Performed all aspects of team management and scheduling, diagnostic procedures and repairs, and automotive customization.