Night QA Manufacturing Specialist I/II — cGMP Batch

KBI Biopharma, Inc.; Boulder (CO); On-site; USD 67,000 - 85,000; Full time

Job summary

KBI Biopharma, Inc. seeks a Quality Assurance Specialist I/II Manufacturing to ensure products, processes, facilities, documentation, and systems meet quality standards, internal procedures, and regulatory requirements.

This role provides broad QA oversight for bulk drug substance manufacturing and reviews executed procedures, equipment logs, and batch records. The position involves authoring SOPs, supporting changeovers, resolving deviations, and collaborating across manufacturing, R&D, and QA

Qualifications

• Bachelor's degree and 2 years of QA experience for Specialist I or 6 years for Specialist II.
• Experience in a cGMP QA environment preferred.
• Familiarity with SOPs, batch records, and change control processes.

Responsibilities

• Perform compliance review on executed records: batch and solution records and relevant logs.
• Author new and revised SOPs, forms/logs, Master Batch Records and Solution Records.
• Support Manufacturing changeover processes.
• Collaborate with Manufacturing, Laboratory and other GMP teams to resolve deviations.
• Author, review, and approve deviation investigations.
• Support QA Raw Material release activities as needed.
• Adapt to changing product needs and perform other essential tasks.

Skills

Quality Assurance

GxP / cGMP

Documentation review

Education

Bachelor's degree

Job description

KBI Biopharma, Inc. seeks a Quality Assurance Specialist I/II Manufacturing to ensure products, processes, facilities, documentation, and systems meet quality standards, internal procedures, and regulatory requirements.

This role provides broad QA oversight for bulk drug substance manufacturing and reviews executed procedures, equipment logs, and batch records. The position involves authoring SOPs, supporting changeovers, resolving deviations, and collaborating across manufacturing, R&D, and QA