QA Specialist II - Deviations & CAPA Champion

KBI Biopharma, Inc.; North Carolina; On-site; USD 70,000 - 100,000; Full time

Job summary

KBI Biopharma, Inc. seeks a QA Specialist for the Deviations and CAPAs team to oversee manufacturing operations and ensure cGMP compliance at our biopharma facility. You will collaborate with Operations and QA staff to resolve deviations and drive CAPAs to closure.

The role involves conducting root cause analysis, supporting change controls, and contributing to training materials. Strong technical writing and communication skills are essential.

Qualifications

• Bachelor’s degree with 3+ years in QA or 1+ years with Master’s in a cGMP biopharmaceutical setting.
• Strong interpersonal skills and attention to detail; team oriented.
• Knowledge of FDA, EU and ROW cGMP regulations; ability to write reports.

Responsibilities

• Resolve GMP deviations and compliance issues in collaboration with Manufacturing QA.
• Review events for classification, initiation and closure; approve Deviations and CAPAs.
• Ensure root cause analysis, CAPAs and effectiveness checks are completed.
• Generate metrics, identify trends, and provide status updates.
• Collaborate across functions to improve the Deviation/CAPA system and training materials.
• Support client audits and regulatory inspections as required.

Skills

QA oversight

cGMP

Deviations

CAPAs

Analytical writing

Regulatory knowledge

Team collaboration

Education

Bachelor’s degree + 3+ years QA

Master’s degree +1+ years QA

Tools

Deviation tracking systems

Job description

KBI Biopharma, Inc. seeks a QA Specialist for the Deviations and CAPAs team to oversee manufacturing operations and ensure cGMP compliance at our biopharma facility. You will collaborate with Operations and QA staff to resolve deviations and drive CAPAs to closure.

The role involves conducting root cause analysis, supporting change controls, and contributing to training materials. Strong technical writing and communication skills are essential.