QA Manufacturing Specialist I/II

Location: Boulder, Colorado, USA; onsite night shift, 4x10 schedule from 19:00 to 05:30

Salary: $67,000–$85,000 annually, plus a night-shift differential

Company

hirify.global provides biopharmaceutical manufacturing operations supporting bulk drug substance production.

What you will do

• Perform compliance reviews of batch and solution records, in-process data, associated forms, and equipment or facility logs.
• Author, review, and approve SOPs, forms, logs, master batch records, solution records, and deviation investigations.
• Support manufacturing changeovers and client batch record review processes.
• Work with manufacturing, laboratory, and other GMP functions to resolve deviations and compliance issues.
• Support the QA Raw Material group with raw material release activities.

Requirements

• Bachelor’s degree.
• QA Specialist I: 2 years of experience; QA Specialist II: 6 years of experience.
• Experience in a cGMP quality assurance environment or equivalent is preferred.
• Ability to work the 4x10 overnight schedule from 19:00 to 05:30 onsite in Boulder, Colorado.

Culture & Benefits

• Full-time employment with a night-shift differential in addition to base salary.
• Equal employment opportunity and affirmative action employer committed to workforce diversity.