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

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. 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.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.