Job Responsibilities:

• Support CAPAs, Change Control, Deviation, Risk Analysis, Root Cause Analysis and other Quality Systems.
• Support Engineering, Validation, Maintenance, and Metrology in the develop and revision of Standard Operating Procedures (SOPs), completion of periodic reviews, and other quality documentation.
• Demonstrate strong technical skills. Provide technical assistance to area supervisors or manages to solve complex problems, Exercise judgement in developing practices, techniques, and evaluation criteria for obtaining results
• Assist in generation of department quality metrics and track the status of active records.
• Complete special projects and other assigned duties to achieve department goals.

Requirements:

Education: / Skills:

• BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Engineering, etc. or equivalent combination of education and experience; 3-5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices including: QA, QC, Validation, Manufacturing, Maintenance, or Engineering.
• Knowledge of the facilities operation typical to the biotechnology/pharmaceutical industry.
• Worked closely with Engineering, Validation, or Maintenance.

Language Ability:

• Ability to read and interpret English documents such as safety rules, operating and maintenance instruction, procedure manuals, batch and production records.
• Ability to write routine reports and correspondence
• Ability to speak effectively before internal groups and employees
• Good deductive and inductive critical thinking skills required.

Reasoning Ability:

• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Strong time management skills and an ability to multitask in a face paced environment.
• Ability to deliver high quality documentation paying attention to detail.
• Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures.

Math Ability:

• Ability to add, subtracts, multiply, and divides 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.

Computer and Equipment Skills:

• Knowledge of and experience using Microsoft Office: Word, Excel, Power Point, Visio Experience.
• Knowledge of and experience using a computer, telephone, copy machine, and fax machine

Range: $74,000.00 / yr. - $102,300.00 / yr.

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.