Position: Facilities Compliance Specialist
About: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe.
Requirements: BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, 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. Ability to read and interpret English documents and write routine reports and correspondence. Strong time management skills and an ability to multitask in a fast-paced environment. Strong technical skills and good deductive and inductive critical thinking skills required. Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures. Ability to solve practical problems and deal with a variety of concrete variables where limited standardization exists. Ability to interpret instructions in various forms. Ability to add, subtract, multiply, and divide in all units of measure, compute rate, ratio, and percentage, and draw and interpret bar graphs.
Benefits: medical, dental, and vision coverage, paid time off and holidays, annual bonus structure, Sabbatical program, 401(k) matching with 100% vesting in 60 days, employee recognition programs