Senior QC Analyst, 2nd Shift — Lab Testing & Data

NCBiotech; Durham (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

KBI Biopharma, located in Durham, NC, seeks a Senior QC Analyst (2nd Shift) to perform analytical testing on in-process, characterization, release, and stability samples using HPLC, ELISA, qPCR and related techniques.

The role emphasizes data integrity and GxP compliance, with responsibilities including method transfer/qualification/validation, data entry into LIMS, investigations, SOP revisions, and on-site collaboration for continuous improvement.

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.
• Execute method transfer, qualification, and validation testing under protocol.
• Prepare solutions and process samples per GxP standards.
• Analyze data independently and enter into control charts/LIMS as applicable.
• Support investigations, deviations, CAPAs, and SOP revisions.
• Assist with STAT testing coordination and on-site lab operations.
• Maintain laboratory safety and audit readiness; ensure cGMP compliance.

Skills

HPLC

ELISA

qPCR

Capillary electrophoresis

LIMS

GxP

Data analysis

Troubleshooting

Education

Bachelor's degree

Tools

LIMS

Job description

KBI Biopharma, located in Durham, NC, seeks a Senior QC Analyst (2nd Shift) to perform analytical testing on in-process, characterization, release, and stability samples using HPLC, ELISA, qPCR and related techniques.

The role emphasizes data integrity and GxP compliance, with responsibilities including method transfer/qualification/validation, data entry into LIMS, investigations, SOP revisions, and on-site collaboration for continuous improvement.