KBI: US - Manufacturing Compliance Specialist I/II (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

Position Summary

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.

Schedule

Mon-Fri, 2:00PM-10:30PM.

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.

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.
• 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.

Salary Range

$ 70,000 - $90,000 per year

Company Information

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

About KBI Biopharma

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them. We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one's technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.