GMP Compliance Investigator & QA Regs Specialist
Duke University
Duke University’s Marcus Center for Cellular Cures seeks a QA Regulatory and Compliance Associate for our on-site GMP manufacturing lab in Durham, NC. You will ensure compliance with FDA and FACT standards, develop SOPs, and manage deviations, CAPAs, and investigations. You will collaborate with QSU and sponsors, prepare deviation reports, support inspections, and educate staff on quality plans while driving continuous process improvements under the GMP Compliance unit. #J-18808-Ljbffr Duke University
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$67.92k - $102.9k
...for Cellular Cures has an immediate opening for a QA Regulatory and Compliance Associate in their GMP lab located at 2400 Pratt Street, Durham, NC. This... ...author and complete deviations, CAPAs, memos, and investigations related to manufacturing. Collaborate with QSU, manufacturing...SuggestedImmediate start- Duke University in Durham, North Carolina is seeking a GMP, Quality Assurance Associate II to help ensure compliance and quality in their GMP programs. In this role, you will work with various partners, supporting quality systems and continuous improvement efforts. The...Suggested
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KBI Biopharma Inc. in Durham, NC is seeking a Principal QA Specialist responsible for compliance review of Biopharmaceutical GMP data. You will provide QA oversight of various laboratory activities and ensure patient safety and regulatory compliance. The ideal candidate...- Sonara Inc. is seeking a Senior QA Manufacturing Specialist in Durham, NC to ensure compliance with quality standards in drug substance manufacturing. You will review... ...field and at least 8 years of experience in a QA GMP environment. Strong interpersonal skills,...
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$55k - $86.9k
...Summary The Manufacturing Quality Assurance (MQA) Specialist supports the manufacturing process within a rapidly expanding GMP contract manufacturing organization. The... ...Responsibilities Support manufacturing with real‑time compliance review of batch records, logbooks, and...Contract workShift work$113k - $156k
## KBI: US - Principal QA SpecialistApplylocations: USA... ...is responsible for the compliance review of Biopharmaceutical GMP data. This includes the review... ...studies, laboratory investigations and laboratory deviations. The Principal QA Specialist provides exemplary service...Immediate start$45.25k - $74.34k
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Bioanalytical Principle Investigator-Biomarkers Updated: Yesterday Location: Morrisville, NC, United States Job ID: 25109687 Bioanalytical... ...in bioanalytical report writing and prioritization. Ensure compliance and evaluate, identify and communicate the regulatory risks...Contract workTemporary workFlexible hours- ...follows a 2-2-3 schedule Job Summary The QA Manufacturing Specialist, Senior is responsible for ensuring... ...Perform on-the-floor compliance review on executed records including... ...and other departments responsible for GMP activities to resolve deviations, CAPAs...Work at officeImmediate startDay shift
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