Night-Shift QA Manufacturing Specialist I/II

Socket.dev; Boulder (CO); On-site; USD 67,000 - 85,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Quality Assurance Specialist I/II Manufacturing to ensure products, processes, facilities, documentation, and systems meet quality standards, internal procedures, and government regulations in support of cGMP operations.

The role includes reviewing records, authoring SOPs and batch records, supporting changeovers, resolving deviations with GMP teams, and assisting with raw material releases and client batch reviews; night shift differential applies.

Qualifications

• Bachelor's degree and 2 years of experience for QA Specialist I.
• Bachelor's degree and 6 years of experience for QA Specialist II.
• Experience in a cGMP QA environment or equivalent is preferred.

Responsibilities

• Perform compliance review on batch and solution records and associated forms, data, and logs
• Author new and revised SOPs, forms/logs, Master Batch Records and Solution Records
• Support Manufacturing changeover process
• Collaborate with GMP teams to resolve deviations in a timely manner
• Author, review, and approve deviation investigations
• Support QA Raw Material release and client batch record review as needed
• Be adaptable to change and perform other essential tasks

Education

Bachelor's degree

Job description

KBI Biopharma, Inc. is seeking a Quality Assurance Specialist I/II Manufacturing to ensure products, processes, facilities, documentation, and systems meet quality standards, internal procedures, and government regulations in support of cGMP operations.

The role includes reviewing records, authoring SOPs and batch records, supporting changeovers, resolving deviations with GMP teams, and assisting with raw material releases and client batch reviews; night shift differential applies.