Senior QA Specialist - Biopharma Compliance & Validation

KBI Biopharma, Inc.; North Carolina; On-site; USD 120,000 - 180,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Principal QA Specialist in North Carolina to lead compliance review of GMP data, oversee QA activities across analytical and microbial labs, and support product lifecycle and regulatory inspections.

The role emphasizes patient safety, regulatory adherence, and cross-functional collaboration. The position requires deep QA/QC and cGMP expertise, with extensive experience in FDA/EU regulations, method qualification, and CAPA processes.

Qualifications

• Bachelor’s degree and 10+ years' experience or Master’s degree and 6+ years' experience in a QA, QC or cGMP environment in Biopharmaceuticals or equivalent.
• Demonstrated strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills.
• Strong understanding of FDA, EU and cGMP regulations is required.
• Experience in Quality Control and Quality Systems is beneficial.

Responsibilities

• Performs timely review of test data for in process, release, and stability samples.
• Assures activities comply with required procedures, cGLP, and cGMP requirements.
• Responsible for the review and approval of method verification, transfer, qualification, and validation related to the testing of in-process, release, and stability testing.
• Provides QA support for Deviations, CAPAs, Laboratory Investigations, Change Controls and Projects related to laboratory processes, instruments, specifications, methods and SOPs.
• Attends relevant operational meetings in support of Manufacturing operation, analysis and disposition activities.
• Supports client audits and regulatory inspections as required.
• Other activities as assigned by Management.
• Provides QA oversight of special projects such as implementation of new processes to support site, operational and department goals.
• Serves as trainer/mentor for QA Specialists and cross-trainer for employees in other departments to support individual development goals.

Skills

QA oversight

cGMP knowledge

Regulatory understanding

Interpersonal skills

Team collaboration

Problem solving

Attention to detail

Quality culture

Education

Bachelor’s degree

Master’s degree

Tools

MS Office

LIMS

Databases

Job description

KBI Biopharma, Inc. is seeking a Principal QA Specialist in North Carolina to lead compliance review of GMP data, oversee QA activities across analytical and microbial labs, and support product lifecycle and regulatory inspections.

The role emphasizes patient safety, regulatory adherence, and cross-functional collaboration. The position requires deep QA/QC and cGMP expertise, with extensive experience in FDA/EU regulations, method qualification, and CAPA processes.