KBI: US - Manufacturing Compliance Specialist I/II (Swing Shift)

KBI Biopharma • Boulder, CO

8d

About The Position

The Manufacturing Compliance Specialist I/II (Swing Shift) supports the Manufacturing department through functional and cross-functional collaboration and teamwork on the Manufacturing floor in a clean room environment. The role is hands-on and supports team needs and department and site objectives. The schedule is Monday through Friday, 2:00 PM to 10:30 PM.

Requirements

• A bachelor's degree in a related scientific discipline and four years of experience in related cGMP manufacturing operations; or a high school degree and seven years of experience; or equivalent.
• Prior experience in GMP operations.
• Knowledge of quality systems and regulatory expectations.
• Organization and strong attention to detail.
• Ability to focus in a fast-paced, multi-tasked environment and maintain operational efficiency with a positive demeanor.

Nice To Haves

• Demonstrated knowledge of upstream (microbial fermentation) or downstream unit operations for biopharmaceutical production.
• Experience with single-use and stainless platform technology.
• Excellent written and verbal communication skills.

Responsibilities

• Engage proactively in face-to-face communication and provide real-time correction, training, and quality-focused guidance during manufacturing floor operations.
• Execute and review batch documentation and logbooks in a timely manner.
• Troubleshoot and reconcile ERP issues.
• Manage materials to ensure proper workflow.
• Ensure area readiness and that cleanrooms meet compliance standards.
• Collaborate with Manufacturing management, floor staff, and QA on process-related mitigation efforts.
• Mentor in collaboration with Manufacturing management, floor staff, and training specialists.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level