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KBI Biopharma Quality Assurance Specialist II - Disposition in Boulder, Colorado

Job Description:Responsible for providing quality assurance support to Manufacturing Processesand Disposition operations. Performs batch disposition of commercial stagebulk drug substance and clinical trial bulk drug substance as part of thecontract manufacturing organization. Activities include deviation approval,change control approvals, analytical summary report review, issueresolution, Master Batch Records and SOP quality document approvals,annual product review writing and complaint investigations. Works directlywith disposition element owners to drive disposition timelines. This positiondoes not have direct reports.Responsible for providing quality assurance support to Manufacturing Processesand Disposition operations. Performs batch disposition of commercial stagebulk drug substance and clinical trial bulk drug substance as part of thecontract manufacturing organization. Activities include deviation approval,change control approvals, analytical summary report review, issueresolution, Master Batch Records and SOP quality document approvals,annual product review writing and complaint investigations. Works directlywith disposition element owners to drive disposition timelines. This positiondoes not have direct reports. Reviews and approves the following records in support of manufacturingoperations: Batch, solution, equipment preparation, and othermanufacturing records as needed. Works directly with Manufacturing, Engineering, MSandT (ManufacturingScience and Technology), Quality Control and Validation to resolve issuesto support commercial and clinical batch disposition. Review and Approval ofChange Controls and Analytical Summary Reports. Supports GMP Manufacturing activities. Review deviations, CAPA's andProcessing Change Controls related to the manufacturing process. Supports Annual Product Review Supports the Complaint Process at KBI Boulder Supports manufacturing to improve quality systems and streamlinemanufacturing processes. May be asked to support project teams.Requirements:Bachelor's and 2 years' experience or Master's and 1 years' experiencein a GMP QA environment or equivalent. Inter and intra department projectmanagement experience and experience with electronic document managementsystems 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 veteran status, arestrongly encouraged to apply.

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