Results-driven Quality Assurance professional with a solid background in laboratory operations and regulatory compliance across the biopharmaceutical, spirits, and food industries. Expertise in conducting analytic tests, supporting clinical R&D, and ensuring strict adherence to ISO, MDR, FDA, CLIA, HACCP, and GMP standards. Proven ability to lead training initiatives, manage quality systems, and enhance productivity through meticulous process improvements and data analysis.Areas of Expertise:▪ Document Control System Management ▪ CAPA Management ▪ SOP Development ▪ Audit Preparation & Support ▪ Regulatory Compliance (ISO, FDA & MDR) ▪ Training & Development ▪ Data Analysis ▪ Organoleptic Testing ▪ Analytical Techniques ▪ GMP, CLIA & GDP Compliance ▪ Cross-Functional Collaboration ▪ Data-Driven Decision ▪ SAP ▪ Veeva ▪ Trackwise
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Quality Control SpecialistPackgene Biotech, Inc. Sep 2024 - PresentUnited States -
Quality SpecialistIngeneron Jan 2023 - Sep 2024Houston, Texas, United States -
Quality Control AnalystLonza Jul 2021 - Jan 2023Houston, Texas, United States -
Quality Control Technologist 2Talaris Therapeutics Jul 2019 - May 2021Louisville, KentuckyPerform analytic tests, including flow cytometry, endotoxin, sterility and cell counts, CFC and other assays related to the quality control of a cell therapy product in accordance with Batch Production Records and approved SOPs and adhering to the applicable regulations and standards, including GMP, GTP, and AABC standards.Participate in clinical research and development, conduct data analysis and prepare reports, working under general supervision. Participate in programmatic organization activities such as equipment maintenance, inventory management, ordering of supplies, preparation of SOPs and facility monitoring and maintenance. Participate in training professionals or graduate students in laboratory procedures and approved SOPs. -
Quality Control Laboratory TechnicianBeam Suntory Jan 2019 - Jul 2019Clermont, KentuckyI ensured the safe and quality production of Bourbon/Spirits through organoleptic testing, analytical techniques via the use of instruments such as titrators, alcolyzers, density meters, viscometers, as well as spectrophotometers, refractometers and many more machines. In addition, I performed walk-through audits of the facility to ensure the lines are suitable for the manufacture and distribution of our products as well as safeguarding the plant through incorporating hazard analysis and critical control points (HACCP) and good manufacturing practice (GMP). If products did not meet the quality standard of our customers and consumers, I utilized SAP and placed them on hold. I did plating and cell counts on yeast from our grains in order to ensure that their viability isn't comprised via contamination or lack of growth from various other factors. I performed data entry and did analysis of large banks of data and followed trends in order to determine the causes of abnormalities and patterns. Lastly, I lead the lab on second shift to insure quality and consistency. -
Quality Control Laboratory Technician 2Treehouse Foods Apr 2017 - Jan 2019Buckner, KentuckyI ensured the safe and quality production of foods through organoleptic testing, analytical techniques via the use of instruments such as titrators, pH meters and viscometers, as well as spectrophotometers and refractometers. In addition, I performed walk-through audits of the facility to ensure the lines are suitable for the manufacture and distribution of our products as well as safeguarding the plant through incorporating hazard analysis and critical control points (HACCP) and good manufacturing practice (GMP). If products did not meet the quality standard of our customers and consumers, I utilized SAP and placed them on hold. My responsibilities also included ATP, APC, allergen swabs and environmental swabbing ensuring the absence of bacterial growth on the lines and allergen cross contamination. I inspected raw materials as they came into the facility and performed audits on them to ensure they were well within standards. I calibrated equipment in the lab and outside of the lab. I performed data entry and did analysis of large banks of data and followed trends in order to determine the causes of abnormalities and patterns. Lastly, I led the lab on third shift and trained lab personnel in order to ensure quality and consistency . -
ExpeditorIngram Micro Aug 2016 - Apr 2017Louisville, KentuckyPick product in a timely manner and accurately, occasional system analysis, fixed any problems physically and systematically and interacted on a multi-departmental level to insure that everything was corrected on all accounts, and made sure the order is completed correctly and that the day is shipped clean. -
InternLouisville Nature Center Inc Jan 2016 - Apr 2016Louisville, Kentucky AreaTaught children in a classroom setting about the local ecology and environment. Took kids on tour around Beargrass creek forest, and taught them about the surrounding environment and species. Took care of the animals within the building. Set up gardens including a rain garden, weeded, and identify/label plants within the gardens. Supervised other volunteers on gardening. Restructured inventory and performed low level maintenance projects. Set up for events and guests that came to the facility.
Steven Bickel Education Details
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Clinical Psychology -
Ecology And Evolutionary Biology
Frequently Asked Questions about Steven Bickel
What company does Steven Bickel work for?
Steven Bickel works for Packgene Biotech, Inc.
What is Steven Bickel's role at the current company?
Steven Bickel's current role is Quality Specialist in BioPharma..
What schools did Steven Bickel attend?
Steven Bickel attended University Of Louisville, University Of Louisville.
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Stephen Bickel
Director Of Digital Marketing And Creative Services For The Pharmaceutical Segment At Cardinal HealthColumbus, Ohio Metropolitan Area2vt.edu, cardinalhealth.com4 +161475XXXXX
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3gmail.com, aol.com, exetergov.com
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