GMP Quality Assurance Associate II

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

Job summary

Duke University is seeking a GMP Quality Assurance Associate II to join the Marcus Center for Cellular Cures (MC3). The role supports QA activities ensuring products, materials, and processes meet high standards of quality and compliance.

You will work with manufacturing, engineering, validation, and quality teams, support investigations, quality metrics, supplier qualifications, inspections, and training, while driving continuous improvement across GMP operations.

Qualifications

• Bachelor’s degree required.
• 5 years in GXMP or similar regulated environment.
• Experience training users in Quality Systems.
• Experience preparing for external audits or site visits.
• Experience reviewing raw materials, supplies, and manufactured products for acceptability.
• Experience with validation/technical quality engineering in manufacturing operations.
• Master’s or PhD may substitute for experience.
• Equivalent education/experience considered.

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.
• 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.

Skills

Quality systems training

Laboratory experience

External audits prep

Raw materials review

Validation engineering support

Leadership

Education

Bachelor’s degree

Bachelor’s degree in life sciences

Job description

Duke University is seeking a GMP Quality Assurance Associate II to join the Marcus Center for Cellular Cures (MC3). The role supports QA activities ensuring products, materials, and processes meet high standards of quality and compliance.

You will work with manufacturing, engineering, validation, and quality teams, support investigations, quality metrics, supplier qualifications, inspections, and training, while driving continuous improvement across GMP operations.