McGhee Orme-Johnson

Quality Audit Lead at Signant Health

McGhee Orme-Johnson, CQA has a diverse work experience in quality assurance and compliance. They started their career as a Research Technician at the Immune Disease Institute, where they worked from August 2009 to August 2011. After that, they joined Moderna Therapeutics as a Research Associate from August 2011 to May 2012 and then moved to TGA Sciences, Inc. as a Research Associate from May 2012 to June 2014.

In 2014, McGhee joined Corbion as a Chemical Analyst, where they were responsible for testing product conformity and improving quality testing processes. They worked there from September 2014 to April 2015. Following that, they joined WIL Research as a Scientist II, performing bioanalytical research and working on GLP and non-GLP studies from April 2015 to June 2016.

In 2016, they joined Charles River Laboratories as a Quality Assurance Auditor I, conducting GLP audits and assisting in client and regulatory audits. From June 2017 to March 2019, they worked as a Quality Assurance Auditor II at the same company, where their responsibilities included performing GLP audits and assisting in the maintenance of Standard Operating Protocols.

After leaving Charles River Laboratories, they joined Vetter Pharma as a Quality Engineer from March 2019 to September 2019. In this role, they contributed to GMP facility operations and lead customer audits. Later, they became a Regulatory Compliance Specialist at Vetter Pharma, a position they held from September 2019 to April 2022. They took charge of leading customer audits, handling customer complaints, and ensuring regulatory compliance.

From April 2022 to June 2023, McGhee worked at Metabolon, Inc. as a Senior Quality Assurance Auditor. They led internal audits, performed GCP audits, supported ISO 9001 certification maintenance, supervised Deviation and CAPA QA, and assisted in customer audits of the company.

Currently, McGhee holds the position of Quality Audit Lead at Signant Health, a role they assumed in June 2023.

McGhee Orme-Johnson, CQA completed a Bachelor's degree in Biochemistry and Religion at Worcester Polytechnic Institute from 2005 to 2009. Additionally, McGhee has obtained certifications as a Certified Quality Auditor from ASQ - World Headquarters and as a Registered Quality Assurance Professional - Good Laboratory Practices from the Society of Quality Assurance. The specific dates of obtaining these certifications are not provided.

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