Stephanie Elsberry, Cqa, Pmp

Stephanie Elsberry, Cqa, Pmp Email and Phone Number

Quality Assurance Professional at Signature Science, LLC @ Signature Science, LLC
austin, texas, united states
Stephanie Elsberry, Cqa, Pmp's Location
Festus, Missouri, United States, United States
Stephanie Elsberry, Cqa, Pmp's Contact Details

Stephanie Elsberry, Cqa, Pmp work email

Stephanie Elsberry, Cqa, Pmp personal email

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About Stephanie Elsberry, Cqa, Pmp

Experienced Quality Assurance professional with proven performance in building and implementing quality management systems in manufacturing environments as well as biological and chemical testing laboratories. Leads cross-functional and inter-departmental teams to accomplish program goals. Effectively communicates with customers, vendors, and partners. Strong technical background in biology, chemistry, and geosciences, supported by a Master of Natural Science degree with a focus in biology and complementary studies in geosciences and a Bachelor of Science (B.S.) degree focused in Zoology with a chemistry minor from Southeast Missouri State University.

Stephanie Elsberry, Cqa, Pmp's Current Company Details
Signature Science, LLC

Signature Science, Llc

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Quality Assurance Professional at Signature Science, LLC
austin, texas, united states
Employees:
185
Stephanie Elsberry, Cqa, Pmp Work Experience Details
  • Signature Science, Llc
    Lead Quality Assurance Engineer
    Signature Science, Llc Oct 2018 - Present
    Austin, Texas Metropolitan Area
    I currently lead the team to provide Quality Assurance for the CHEMERA manufacturing product line. The CHEMERA is a ruggedized, fieldable chemical identifier based on QIT-TOF MS technology. I led the team to develop and continue to maintain the ISO 9001:2015 certified CHEMERA quality management system.
  • Signature Science, Llc
    Senior Quality Assurance Biologist
    Signature Science, Llc May 2013 - Present
    Austin, Texas, United States
    Subject Matter Expert for U.S. Government chemical and biological testing laboratory networks.- Creates and maintains manufacturing, laboratory, and proficiency test Quality Management Systems (QMS) to relevant standards (ISO 9001, ISO 17025, and ISO 17043). - Lead auditor for subcontractor audits, third party audits, and internal audits to ISO 9001, ISO 17025, ISO 17043, and local requirements. Manage audit schedule and process and lead audit responses.- Manage and lead… Show more Subject Matter Expert for U.S. Government chemical and biological testing laboratory networks.- Creates and maintains manufacturing, laboratory, and proficiency test Quality Management Systems (QMS) to relevant standards (ISO 9001, ISO 17025, and ISO 17043). - Lead auditor for subcontractor audits, third party audits, and internal audits to ISO 9001, ISO 17025, ISO 17043, and local requirements. Manage audit schedule and process and lead audit responses.- Manage and lead corrective actions, nonconformities, and deviations. - Trainer: Root Cause Investigation and Corrective Action, ISO 9001, ISO 17025, and ISO 17043.- Domestic travel 50% Show less
  • Bioeden, Inc.
    Laboratory Manager
    Bioeden, Inc. Dec 2010 - Apr 2013
    Austin, Texas, United States
    Laboratory manager for the world’s first international biobank company to collect, assess, and cryogenically store living stem cells from human teeth.- Developed and maintained QMS compliant to 21CFR1271 and ISO 9001. - Hosted and responded to FDA and external audits. Supported MHRA inspection and response for UK branch.- Managed corrective action process.- Purchasing and consumables and equipment inventory management.- Product labeling.- Delivered QMS and BBP… Show more Laboratory manager for the world’s first international biobank company to collect, assess, and cryogenically store living stem cells from human teeth.- Developed and maintained QMS compliant to 21CFR1271 and ISO 9001. - Hosted and responded to FDA and external audits. Supported MHRA inspection and response for UK branch.- Managed corrective action process.- Purchasing and consumables and equipment inventory management.- Product labeling.- Delivered QMS and BBP training to staff of 10. Show less
  • Bioeden, Inc.
    Senior Scientist
    Bioeden, Inc. Nov 2008 - Dec 2010
  • Asuragen
    Scientist 1
    Asuragen Mar 2006 - Jan 2009
    Austin, Texas, United States
    Asuragen is a fully integrated RNA-based therapeutic and diagnostics company with a core focus on miRNA.Oncology diagnosis team member. Developed early stage qRT-PCR diagnostic assays using human biofluids.- Expert in conventional and high-throughput real time RT-PCR (ABI 7500 and ABI 7900), cell culture, and nucleic acid extraction methods. - Performed work in an ISO 13485 (Medical Devices) certified laboratory.
  • Asuragen
    Research Assistant Ii
    Asuragen Nov 2005 - Mar 2006
    United States
    The RNA Company. My group spun out from Ambion during their acquisition by Life Technologies to become Asuragen.Oncology diagnosis team member. Developed early stage qRT-PCR diagnostic assays using human biofluids.- Expert in conventional and high-throughput real time RT-PCR (ABI 7500 and ABI 7900), cell culture, and nucleic acid extraction methods. - Performed work in an ISO 13485 (Medical Devices) certified laboratory.
  • Association Of Public Health Laboratories
    Fellow
    Association Of Public Health Laboratories Aug 2004 - Aug 2005
    Austin, Texas, United States
    One of 30 scientists to earn this competitive, year-long Emerging Infectious Diseases (EID) Laboratory Fellowship Program, a training fellowship supporting local public health initiatives. Assigned to the Texas Department of State Health Services to develop and validate TaqMan and SYBR Green I RT-PCR assays for Dengue virus detection in mosquitoes in a BSL3 laboratory."The EID Advanced Laboratory Training Fellowship is a one-year program designed for bachelor’s or master’s level… Show more One of 30 scientists to earn this competitive, year-long Emerging Infectious Diseases (EID) Laboratory Fellowship Program, a training fellowship supporting local public health initiatives. Assigned to the Texas Department of State Health Services to develop and validate TaqMan and SYBR Green I RT-PCR assays for Dengue virus detection in mosquitoes in a BSL3 laboratory."The EID Advanced Laboratory Training Fellowship is a one-year program designed for bachelor’s or master’s level scientists, with emphasis on the practical application of technologies, methodologies and practices related to emerging infectious diseases."In addition to applying laboratory techniques such as nucleic acid extraction and RT-PCR, I was exposed for the first time to the world of public health. In this role, I was allowed to participate in stakeholder teleconferences related to food-borne illnesses, West Nile Virus detection, and MRSA infections. I also participated in the oral rabies vaccination program, which is an exciting aerial vaccine distribution program to control endemic rabies in border populations of coyote and fox. Show less

Stephanie Elsberry, Cqa, Pmp Skills

Molecular Biology Cell Culture Rt Pcr Biotechnology Quality Assurance Qpcr Life Sciences Laboratory Lifesciences Sop Development Gel Electrophoresis Elisa Pcr Cell Biology Mammalian Cell Culture Primary Cell Isolation Regulatory Affairs Biochemistry Microbiology Assay Development Genomics Cell Staff Supervision Quality System Compliance Rna Isolation Asq Cqa Quality Auditing Quality Management Systems Root Cause Analysis Capa Technical Writing Iso 9001 Internal Audit U.s. Food And Drug Administration Iso 9001 Microsoft Office Iso 17043 21cfr1271 Cfr Toastmasters Iso 17025 Texas Cottage Food Law Product Development Written Communication Interpersonal Relationships Cross Functional Team Leadership

Stephanie Elsberry, Cqa, Pmp Education Details

Frequently Asked Questions about Stephanie Elsberry, Cqa, Pmp

What company does Stephanie Elsberry, Cqa, Pmp work for?

Stephanie Elsberry, Cqa, Pmp works for Signature Science, Llc

What is Stephanie Elsberry, Cqa, Pmp's role at the current company?

Stephanie Elsberry, Cqa, Pmp's current role is Quality Assurance Professional at Signature Science, LLC.

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What schools did Stephanie Elsberry, Cqa, Pmp attend?

Stephanie Elsberry, Cqa, Pmp attended Southeast Missouri State University, Southeast Missouri State University, Southeast Missouri State University.

What skills is Stephanie Elsberry, Cqa, Pmp known for?

Stephanie Elsberry, Cqa, Pmp has skills like Molecular Biology, Cell Culture, Rt Pcr, Biotechnology, Quality Assurance, Qpcr, Life Sciences, Laboratory, Lifesciences, Sop Development, Gel Electrophoresis, Elisa.

Who are Stephanie Elsberry, Cqa, Pmp's colleagues?

Stephanie Elsberry, Cqa, Pmp's colleagues are Cody Dove, David Alley, Ed Tovar, Barbara Hayes, Alexis Skidmore, Ian Winsheimer, Bill Thompson.

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