<p>At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.</p> <p>Position Summary:</p> <p>Perform the day-to-day management and distribution of samples and materials.</p> <p>Primarily responsible for chain of custody samples and reference materials and</p> <p>performing stability activities in compliance with standard operating procedures, safety, and cGMP regulations. Perform activities related to compliance as delegated. Responsible for all associated documentation and for maintenance of stability/sample coordination areas. Assist with compliance activities within the sample management area and laboratories as applicable.</p> <p>Responsibilities:</p> <ul> <li> <p>Receive, log, and distribute samples and reference materials per SOPs, maintaining Chain of Custody</p> </li><li> <p>Maintain inventory, storage, and maintenance of samples and reference materials. Assist with shipment of materials as requested following SOPs</p> </li><li> <p>Act as contact for scheduling stability activities. Perform stability activities per SOP and approved study protocols including staging, pulls, and distribution of samples. Responsible for associated documentation and management of pull schedules</p> </li><li> <p>Participate in compliance activities as delegated</p> </li><li> <p>Maintain, organize, and keep clean the sample management room and other work areas. This includes CTU cleaning as required, proper labeling, handling, and storage of any chemicals used in the area and disposing of hazardous/non-hazardous waste as required</p> </li><li> <p>Review chamber monitoring system data routinely per SOP. Act as a primary contact for monitoring system for stability chambers during business hours. Assist in investigation and resolution of excursions or other deviations</p> </li><li> <p>Recognize areas for improvement and share ideas to implement new processes or systems</p> </li></ul> <p>Requirements:</p> <ul> <li> <p>Bachelor's plus minimum of 2 years of industry or lab experience</p> </li><li> <p>General knowledge of cGMP and GLP practices</p> </li><li> <p>Good oral and written communication skills.</p> </li><li> <p>Language Ability: Ability to read and comprehend instructions, correspondence, and memos. Ability to author routine correspondence. Ability to respond to common inquiries or complaints from employees and/or clients. Ability to respond effectively to the most sensitive inquiries or complaints.</p> </li><li> <p>Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written or oral form. Ability to interpret a variety of instructions furnished in written or oral form.</p> </li><li> <p>Math Ability: Ability of basic math, measure, compute rate and percentages.</p> </li><li> <p>Physical Demands: Ability to sit, stand, and walk. Ability to lift 25lbs and push cart with materials</p> </li><li> <p>Computer Skills: Word processing, Spreadsheets, Internet, E-mail.</p> </li></ul> <p>Salary Range: $56,088 - $67,306</p> <p>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.</p> <p>About KBI:</p> <p>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. For more information, visit www.kbibiopharma.com.</p> <p>KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.</p> <p>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.</p> <p>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.</p> <p>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.</p> <p>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.</p>