Senior QA Specialist - GMP Compliance & Lab Oversight

KBI Biopharma; Durham (NC); On-site; USD 120,000 - 150,000; Full time

Job summary

KBI Biopharma is seeking a Principal QA Specialist to oversee the compliance review of biopharmaceutical GMP data, including in-process, release, and stability tests. The role ensures QA oversight of analytical and microbial labs, supports product lifecycle activities, and collaborates across client and internal teams to meet site goals.

The incumbent will lead QA activities, train staff, and mentor other QA specialists while maintaining a strong quality culture to ensure patient safety and

Qualifications

• Must have strong interpersonal skills and demonstrated problem solving abilities.
• Ability to work in a team environment and collaborate with cross-functional stakeholders.
• Solid understanding of FDA, EU and cGMP regulations is required.

Responsibilities

• Perform timely review of test data for in-process, release, and stability samples ensuring compliance with procedures and cGLP/cGMP requirements.
• Review and approve method verification, transfer, qualification, and validation related to testing.
• Provide QA support for deviations, CAPAs, investigations, change controls and related projects.

Skills

Interpersonal skills

Team orientation

Problem solving

FDA/EU regulatory knowledge

Education

Bachelor’s or Master’s in relevant field with required experience

Tools

Microsoft Office

LIMS

Job description

KBI Biopharma is seeking a Principal QA Specialist to oversee the compliance review of biopharmaceutical GMP data, including in-process, release, and stability tests. The role ensures QA oversight of analytical and microbial labs, supports product lifecycle activities, and collaborates across client and internal teams to meet site goals.

The incumbent will lead QA activities, train staff, and mentor other QA specialists while maintaining a strong quality culture to ensure patient safety and