Karen Burt Email and Phone Number

Responsible for the quality management and oversight of suppliers of critical materials and services to GSK manufacturing sites globally. Activities include primarily audit management, CAPA management, risk identification associated with quality audits, support of Quality Agreements, and associated documentation related to critical materials. Currently managing a team of 7 auditors, located across North America, UK, and Middle East/Africa. Have previously managed a team of up to 11… Show more Responsible for the quality management and oversight of suppliers of critical materials and services to GSK manufacturing sites globally. Activities include primarily audit management, CAPA management, risk identification associated with quality audits, support of Quality Agreements, and associated documentation related to critical materials. Currently managing a team of 7 auditors, located across North America, UK, and Middle East/Africa. Have previously managed a team of up to 11 auditors. Strengths: QA/QC, auditing, supplier quality, change control, experience working and managing remotely Show less

Performing Supplier Audits across North America - the US and Canada.

QA Lead in Compliance and Auditing. This involves managing our vendor audit program as well as the internal audit schedule. Both of these are ongoing programs with routine assessments done on a regular basis. Previously within GSK, I was involved in approval and release of raw materials and final product from our Biopharm manufacturing site in Conshohocken, Pennsylvania. This included experience with review and approval of inventory through a BPCS system and LIMS (laboratory… Show more QA Lead in Compliance and Auditing. This involves managing our vendor audit program as well as the internal audit schedule. Both of these are ongoing programs with routine assessments done on a regular basis. Previously within GSK, I was involved in approval and release of raw materials and final product from our Biopharm manufacturing site in Conshohocken, Pennsylvania. This included experience with review and approval of inventory through a BPCS system and LIMS (laboratory information management system). Show less

- Validation of laboratory methods and instrumentation- Troubleshooting of methods and instrumentation- Writing and revising technical documents like design specifications, policies, and procedures related to Quality Control.- Focused on support of biochemistry, chemistry, and cell culture labs