Senior QA Reviewer, CGMP Biopharma Data

KBI Biopharma, Inc.; Durham (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, North Carolina is looking for a qualified individual to oversee the compliance review of biopharmaceutical development GMP data. This role involves reviewing and approving release, in-process, and stability test data, as well as method qualifications, validations, and laboratory investigations.

The ideal candidate has a BS with 11+ years or MS with 8+ years in a regulated environment, along with substantial experience in QA data review, knowledge of USP, EU, and JP cGMP guidelines, and excellent analytical skills.

Qualifications

• BS with 11+ years or MS with 8+ years in a CGMP regulated environment.
• Experience in QA review of analytical data and method validations.
• Ability to interpret regulatory guidelines and write reports.

Responsibilities

• Perform compliance review on release, in‑process, and stability data.
• Review and approve method qualifications and validations.
• Conduct reviews on deviations and laboratory investigations.

Skills

Quality Assurance review

Data analysis

Regulatory guidelines knowledge

Problem-solving

Basic math and statistics

Education

BS with 11+ years experience or MS with 8+ years experience

Tools

Microsoft Word

Microsoft Excel

Database software

Job description

KBI Biopharma, Inc. in Durham, North Carolina is looking for a qualified individual to oversee the compliance review of biopharmaceutical development GMP data. This role involves reviewing and approving release, in-process, and stability test data, as well as method qualifications, validations, and laboratory investigations.

The ideal candidate has a BS with 11+ years or MS with 8+ years in a regulated environment, along with substantial experience in QA data review, knowledge of USP, EU, and JP cGMP guidelines, and excellent analytical skills.