QA Specialist II: Deviations & CAPAs Expert

KBI Biopharma, Inc.; Durham (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a QA Specialist for the Deviations and CAPAs team to oversee GMP manufacturing operations at our Durham facility.

The role collaborates with Operations Compliance and other functions to resolve deviations, classify events, and ensure robust investigations and CAPAs. Candidates should have a Bachelor's degree with 3+ years in QA or cGMP in biopharma, or a Master's with 1+ year.

Qualifications

• Bachelor’s degree with 3+ years’ QA or cGMP in biopharma, or Master’s with 1+ year.
• Strong interpersonal skills and ability to present technical concepts clearly.
• Ability to read, analyze, and interpret regulatory documents and procedures.
• Willingness to collaborate with multiple departments to ensure compliance.

Responsibilities

• Resolve production deviations and compliance issues in a timely manner.
• Review, classify, and close events; prepare RCA and CAPA documentation.
• Approve Deviations and CAPAs; track effectiveness checks.
• Support client audits and regulatory inspections as required.

Skills

QA experience

cGMP knowledge

cross-functional collaboration

technical writing

problem-solving

Education

Bachelor’s degree with 3+ years QA

Master’s degree with 1+ year QA

Job description

KBI Biopharma, Inc. is seeking a QA Specialist for the Deviations and CAPAs team to oversee GMP manufacturing operations at our Durham facility.

The role collaborates with Operations Compliance and other functions to resolve deviations, classify events, and ensure robust investigations and CAPAs. Candidates should have a Bachelor's degree with 3+ years in QA or cGMP in biopharma, or a Master's with 1+ year.