Job Description

Support cGMP manufacturing operations for manufactured biopharmaceutical products. Responsibilities include:Lead Deviation Investigations Collect information, Review documentation, Conduct interviews, Perform Root Cause Analysis, Determine Product Impact, Identify CAPA(s), and Author deviation investigation reports. Lead CAPA implementation as applicable. Generate, revise, and review of standard operating procedures (SOP's) for process equipment and procedures used for production operations. Maintain records to comply with regulatory requirements and cGMPs. Interface effectively with management personnel across Manufacturing, Quality, Engineering and other technical disciplines. Interface effectively with clients while collaborating to determine deviation root cause(s) and impact Work independently, as a member of a team (including matrixed organizational structures), and work with external contractors to meet project needs and timelines.

Position ResponsibilitiesProvide technical writing and investigation support for deviation reports generated at the KBI Boulder site. Support the management of quality systems programs including deviations, CAPAs, and continuousimprovement. Support the implementation of CAPAs or authoring and review of batch documentation.

Position RequirementsBS/BA and minimum 7+ year's related industry experience or MS/MA and minimum 4+ year's related industry experience Ability to read and interpret English documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Ability to solve practical problems and deal with a variety of concrete variables in situations where onlylimited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram,or schedule form. Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions,and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Seeing, sitting, standing, walking, typing.
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.