On-Floor GMP Compliance Specialist (Swing Shift)

KBI Biopharma, Inc.; Boulder (CO); On-site; USD 70,000 - 90,000; Full time

Job summary

KBI Biopharma, Inc. is hiring a Manufacturing Compliance Specialist I/II on the swing shift to support cGMP manufacturing operations in a cleanroom environment.

You will work hands-on on the floor, deliver practical quality guidance, and partner with QA and Manufacturing to meet site goals. The role requires a Bachelor's degree in a related science with experience, or equivalent, and strong detail orientation, GMP knowledge, and effective communication to mentor staff and improve processes on a

Qualifications

• Bachelor's degree in a related scientific discipline with 4 years of cGMP manufacturing experience.
• High school diploma with 7 years experience in cGMP manufacturing.
• Strong organizational skills, detail-oriented, able to multitask in a fast-paced environment.
• GMP operations, quality systems and regulatory knowledge required.
• Experience with upstream or downstream biotech operations preferred.
• Experience with single-use and stainless platform technology preferred.

Responsibilities

• Provide real-time on-the-floor quality guidance and training.
• Timely execution and review of batch documentation/logbooks.
• Troubleshoot and reconcile ERP issues.
• Manage materials ensuring proper workflow.
• Ensure cleanrooms meet compliance standards.
• Collaborate with Manufacturing, QA, and management on process improvements.
• Mentor floor staff with training specialists.

Skills

Attention to detail

GMP operations

Quality systems

Regulatory expectations

Communication skills

Education

Bachelor's degree in a related scientific discipline

High school diploma with 7 years experience

Tools

ERP systems

Single-use platforms

Stainless platform technology

Job description

KBI Biopharma, Inc. is hiring a Manufacturing Compliance Specialist I/II on the swing shift to support cGMP manufacturing operations in a cleanroom environment.

You will work hands-on on the floor, deliver practical quality guidance, and partner with QA and Manufacturing to meet site goals. The role requires a Bachelor's degree in a related science with experience, or equivalent, and strong detail orientation, GMP knowledge, and effective communication to mentor staff and improve processes on a