MS&T Document Specialist

Position Summary

This role is critical to successful introduction of new and existing programs at KBI’s Boulder, Colorado manufacturing facility. Successful introduction requires an aptitude for quality, detail and manufacturing processes, ensuring that documents are built for error free execution by manufacturing staff. This individual will manage the generation, revision, review, scheduling and bill of materials for batch records.

Positions Responsibilities

• Draft and revise batch records within quality system.
• Update and implement bill of materials within enterprise planning system.
• Communicate and coordinate with internal customers and peers.
• May own change controls within quality system.
• May own corrective action within quality system.

Position Requirements

Bachelor’s degree in a related scientific or engineering discipline and 2+ years industry experience in biopharmaceutical manufacturing(fermentation, cell culture, purification); or 5+ years related experience and/or training; or equivalent.

Salary Range: $58,700-$74,100

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

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.