Onsite GMP QA Associate II – Quality & Compliance

Duke PF; Durham (NC); On-site; USD 86,714 - 140,129; Full time

Job summary

Duke University is seeking a GMP, Quality Assurance Associate II to ensure products, materials, and processes in Duke’s GMP programs meet the highest quality and compliance standards. You will support the MC3 GMP Facility, partnering across manufacturing, engineering, validation, and quality to drive quality systems and inspections.

You will help shape continuous improvement, maintain quality metrics, and participate in multiple development programs, with on-site work and a competitive pay range

Qualifications

• Bachelor’s degree required.
• 5 years of experience in a GXMP or similar regulated environment.
• Experience training users in implementing Quality Systems.
• Prior laboratory experience preferred.
• Experience preparing for external audits and/or site visits.
• Experience reviewing raw materials, supplies, and manufactured products for acceptability.
• Master’s or PhD may substitute for experience.
• Or any equivalent combination of relevant education and/or experience.

Responsibilities

• Review and support change control for development, modification, and manufacturing process changes.
• Represent QA in project meetings and provide quality guidance.
• Write, revise, and review SOPs to support compliant operations.
• Lead or support continuous improvement initiatives across GMP programs.
• Track and trend quality metrics to identify areas of concern.
• Assist with inspections and manage quality‑related matters during audits.
• Review and guide deviations and investigations, collaborating with end users to resolve issues.
• Train staff on GMP principles, investigations, and root cause analysis.
• Review product records for release of clinical trial materials and components, when required.
• Participate in multiple programs across various development phases.
• Conduct environmental monitoring and assist with data analysis, when required.
• Conduct audits under the supervision of the Lead Auditor and generate audit reports.

Skills

Quality Systems Training

GXP/GMP knowledge

Quality Assurance

Documentation & SOP review

Communication & leadership

Analytical/problem solving

Education

Bachelor’s degree

Bachelor’s degree in life sciences or related field

Job description

Duke University is seeking a GMP, Quality Assurance Associate II to ensure products, materials, and processes in Duke’s GMP programs meet the highest quality and compliance standards. You will support the MC3 GMP Facility, partnering across manufacturing, engineering, validation, and quality to drive quality systems and inspections.

You will help shape continuous improvement, maintain quality metrics, and participate in multiple development programs, with on-site work and a competitive pay range