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

KBI Biopharma • Boulder, CO

1d • $70,000 - $90,000 • Onsite

About The Position

The Manufacturing Compliance Specialist I/II (Swing Shift) is reporting to the Manufacturing department and responsible for supporting Manufacturing through functional/cross-functional collaboration and teamwork supporting the team on the Manufacturing floor, in a clean room environment. This role will serve as hands-on, delivering to the needs of the team, meeting department/site objectives.

Requirements

• Bachelor’s degree in a related scientific discipline and 4 years’ experience in related cGMP manufacturing operations; or high school degree and 7 years’ experience, or equivalent.
• Must be organized with strong attention to detail, able to focus in a fast-paced, multi-tasked environment, and maintain operational efficiency with a positive demeanor.
• Prior experience in GMP operations is required.
• Knowledge of quality systems and regulatory expectations is required.

Nice To Haves

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

Responsibilities

• Proactively engages in “Face to Face” communication and provide real time correction, training and quality focused guidance during 'On the Floor' Manufacturing Operations.
• Timely execution and review of batch documentation/logbooks.
• ERP troubleshooting/reconciliation.
• Material management ensuring proper workflow.
• Area readiness ensuring cleanrooms are meeting compliance standards.
• Collaborate with Manufacturing management, floor staff, and QA on any process related mitigation efforts.
• Mentoring in collaboration with Manufacturing management, floor staff, and training specialists.

What This Job Offers

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