2nd-Shift QC Analyst — Biopharma Method Expert

KBI Biopharma, Inc.; Durham (NC); On-site; USD 63,000 - 87,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Senior QC Analyst (2nd Shift) to perform analytical testing across in-process, characterization, release, and stability samples.

The role emphasizes adherence to cGMP, data integrity, and timely reporting while supporting CAPA and deviation investigations. Responsibilities include executing HPLC, ELISA, qPCR, and other spectrophotometric techniques, performing method transfers and validations, and ensuring 2nd shift coverage onsite with strong collaboration

Qualifications

• Relevant degree and 4-8 years’ biopharmaceutical industry experience, preferably in protein analytics.

Responsibilities

• In-process, characterization, stability, and/or release testing using HPLC, ELISA, qPCR and related techniques.
• Execution of method transfer, method qualification, and/or method validation testing performed under protocol.
• Solution preparation.
• Organizes and processes samples according to GxP standards.
• Independent analysis and collation of data to draw conclusions.
• Enter data into control charts and LIMS, if applicable.
• Supports lab investigation and deviation reports.
• Supports implementation of Corrective and Preventive Actions.
• Revises SOPs and technical documents.
• Supports team to troubleshoot testing or project challenges with data presentation.

Skills

Analytical testing

GxP compliance

Data interpretation

Lab teamwork

Education

Bachelor's degree

Job description

KBI Biopharma, Inc. is seeking a Senior QC Analyst (2nd Shift) to perform analytical testing across in-process, characterization, release, and stability samples.

The role emphasizes adherence to cGMP, data integrity, and timely reporting while supporting CAPA and deviation investigations. Responsibilities include executing HPLC, ELISA, qPCR, and other spectrophotometric techniques, performing method transfers and validations, and ensuring 2nd shift coverage onsite with strong collaboration