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KBI Biopharma Quality Assurance Specialist I/II - Line Operations in Boulder, Colorado

This position will provide a broad range of quality oversight for activitiesthat support bulk drug substance manufacturing. Responsible for qualityoversight of manufacturing floor operations, facility/utilityqualification and maintenance oversight, and QC laboratory support. Thisposition will be responsible for review and approval of procedures and methodssupporting all aspects of GMP operations, including support of client andregulatory audits.Major Responsibilities:Performs compliance review on GMP records including:Approves procedures, specifications, test methods, sampling plans, andforms which may impact material or product quality.Approves changes, validation documents, and maintenance work plans.Approves minor deviations and lab investigations.Works directly with manufacturing, the laboratory and other departmentsresponsible for GMP activities to resolve compliance issues in a timelymanner.Experience:BS and 4+ years' experience or MS and 2+ years' experience in a GMP QAenvironment or equivalent. Inter and intra departmental project managementexperience and experience with electronic document management systems desired.KBI 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 Vietnam veteranstatus, are strongly encouraged to apply.

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