GMP QA & Regulatory Compliance Associate

Duke Clinical Research Institute; Durham (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Tuition assistance

Job summary

Join the Duke University Marcus Center for Cellular Cures in Durham, NC as a QA Regulatory and Compliance Associate in our GMP lab. This role focuses on enabling FDA and FACT compliance for GMP cellular products, managing deviations, CAPAs, and SOPs, and preparing for inspections.

The ideal candidate has a biology background and 6 years of QA/QC experience related to clinical trials, with strong communication and organizational skills to educate staff and drive quality programs.

Qualifications

• Bachelor's degree in biological science required.
• Six years of experience in QA or QC related to clinical trials.
• A Master's degree may substitute for 2 years of experience.
• Equivalent combination of relevant education and/or experience accepted.

Responsibilities

• Ensure compliance of the MC3's Carolinas Cord Blood Bank with FDA regulations and FACT accreditation standards.
• Lead deviations and investigations, CAPAs, memos to file, complaints and adverse events related to GMP cellular product.
• Develop/edit SOPs to ensure compliance with FDA and other requirements.
• Assist inspections from FDA, FACT, and other agencies and respond to observations.

Skills

Attention to detail

Excellent communication

Organizational skills

Interpersonal skills

Analytical skills

Self-directed work style

Education

Bachelor's degree in biological science

Master's degree may substitute for 2 years experience

Job description

Join the Duke University Marcus Center for Cellular Cures in Durham, NC as a QA Regulatory and Compliance Associate in our GMP lab. This role focuses on enabling FDA and FACT compliance for GMP cellular products, managing deviations, CAPAs, and SOPs, and preparing for inspections.

The ideal candidate has a biology background and 6 years of QA/QC experience related to clinical trials, with strong communication and organizational skills to educate staff and drive quality programs.