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
Vacancy posted 3 days ago
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$67.92k - $102.9k
GMP Compliance Investigator - Equipment and Facilities - Marcus Center for Cellular Cures Work Arrangement: On-Site Requisition Number: 272207 Regular... ...Center for Cellular Cures has an immediate opening for a QA Regulatory and Compliance Associate in their GMP lab...SuggestedTemporary workWork experience placementImmediate startWorldwide- Duke University’s Marcus Center for Cellular Cures seeks a GMP Compliance Investigator - Equipment and Facilities to ensure FDA and FACT-compliant... ...manufacturing lab operations in Durham, NC. The role focuses on QA/regulatory activities for cGMP programs, deviations, CAPAs,...Suggested
- ...Center for Cellular Cures at Duke University is seeking a GMP Compliance Investigator - Equipment and Facilities for its on-site Durham lab. The... ...developing SOPs, handling deviations and CAPAs, coordinating with QA and Process Development, and supporting batch release...Suggested
$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- GMP Compliance Investigator - Equipment & Facilities Overview Our client is seeking a GMP Compliance Investigator - Equipment & Facilities to support a GMP manufacturing laboratory focused on advanced cellular therapies. This individual will play a key role in maintaining...SuggestedLocal area
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$86.71k - $140.13k
...community of outstanding learners, investigators, clinicians, and staff where... ...(ORAQ) is looking for a GMP, Quality Assurance Associate... ...highest standards of quality and compliance. You will play a key part in... ...Experience serving as final QA signature for release of raw...Work experience placementWork at officeShift work- A leading life sciences consulting firm is looking for a QA Consultant in Morrisville, NC. The successful candidate will provide quality oversight of GMP systems, manage investigations and ensure compliance with regulations. Candidates should possess a bachelor's degree...
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$43.08 - $80 per hour
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Durham, NC12 days ago- ...position is responsible for the compliance review of Biopharmaceutical Development GMP data. This includes the review and... ..., as well as laboratory investigations and deviations associated with the... ...biopharmaceuticals or equivalent. Experience in QA review of analytical data (...
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Integrated Resources
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$138.6k - $257.4k
...Description SummaryJoin Novartis as our QA Operations Head and play a pivotal role... ...that meet the highest standards of safety, compliance, and reliability. This is an opportunity... ..., and disposition activities.Drive investigation of deviations, out-of-expectation results...Full time$169k - $200k
...meaningful work? Now’s your chance.The Opportunity As the Principal Investigator, you will be responsible for delivering end-to-end scientific... ...scientific rigor, methodological consistency, and regulatory compliance of study screening, data extraction, quality assessment, and...Contract workWorldwideFlexible hours- ...of business (LoB)), Quality Assurance (QA) presence & process confirmation on shop... ...Essential Functions Ensure site compliance with Regulations, International Organization... ...documentation Support, review & approve investigations & root-cause analysis using LEAN tools...Local areaShift workAfternoon shift
Novo Nordisk
Durham, NCmore than 2 months ago - ...of business (LoB)), Quality Assurance (QA) presence & process confirmation on shop... ...Assurance. Essential Functions Ensure site compliance with Regulations, International... ...documentation Support, review & approve investigations & root-cause analysis using LEAN tools and...Local areaShift workAfternoon shift
$28 - $31 per hour
...Manager’s note: This is a supportive QA role focused on Review and approval of... ...include but are not limited to a review of GMP raw data for compliance. The QA Associate II will perform all... ...notified about new Quality Assurance Specialist jobs in Durham, NC . REMOTE - Quality...Contract workFor contractorsRemote workNight shift
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