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KBI Biopharma Manager Quality Assurance Line Operations in Boulder, Colorado

Manages the Quality Line Operations department responsible for QA on the floorin manufacturing, real time batch record review, review and resolution ofdeviations, review and approval of CAPAs, SOP review and approval,supports client and regulatory audits, trains and mentors staff.Responsible for QA Line Operations staff located at KBI Biopharma Boulder.Provides overall direction to QA Line Operations staff responsible for QA onthe floor in manufacturing, review of methods validation, andinvestigations into deviations, review and approval of CAPAs, review,identify, prioritize and implement or coordinate change improvement totechnology, people and/or processes to assure compliance with regulatoryand organization policies/procedures and to maximize process efficiency andconProvide overall direction for QA Line Operations assuring compliance withcurrent applicable regulations, client agreements, and KBI standards andpoliciesReviews technical problems and procedures of department and recommendssolutions to problems or changes in procedures.Responsible for assuring that departmental and company employees comply withrequired procedures.Able to react to change productively and handle other essential tasks asassigned.Experience:Minimum of Bachelor's degree in a scientific or related discipline.10 years' experience in pharmaceutical, biological, Quality Assurance(Research and Development experience helpful) with at least 3 years ofsupervisory experience Requires thorough knowledge of GMP guidelines as theyrelate to all aspects of quality systems and compliance.Also requires a demonstrated track record in the following key areas:Strong orientation for Quality and Customer ServiceDemonstrated level of respect for individualsHigh level of integrity and personal responsibilityStrong collaboration and team building skillsKBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversifyits work force. Therefore, all qualified applicants, regardlessof race, color, national origin, religion, gender, genderidentity, sexual orientation, age, disability or veteran status, arestrongly encouraged to apply.

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