Incoming QC Supervisor

Essential Job Functions:

• Execute and maintain the INCOG material qualification program.
• Develop and maintain material specifications.
• Coordinate and execute material sampling activities, inclusive of physical sampling and testing, sampling for 3rd Party analysis and performing ERP transactions. 
• Coordinate and design sampling plans and author and issue certificates of analysis templates. 
• Participate in material planning and Ready to Execute meetings to provide updates on material sampling and material release. 
• Lead laboratory investigations using troubleshooting tools to identify errors, and exercise rapid decision making to implement corrective actions during OOS/OOT and other non-conformance events.
• Utilize various paper and automated systems (QMS, LIMS, etc.) to manage local QC and site policies, procedures, and technical reports throughout document lifecycles including authoring, reviewing, approving, and retiring.
• Use applied statistics to analyze test results to identify sources of error in laboratory and manufacturing processes. Use data trends to apply a systematic approach to continuous improvement.

Special Job Requirements:

• Bachelor’s degree in science.
• Minimum of 5 years of biopharma industry experience, of which at least 2 years have been in a role of hands-on experience with Quality Control in a regulated environment.
• Experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Quality Control.
• Experience with statistical sampling and defect criteria establishment. 
• First-hand experience participating in and/or hosting audits/inspections related to Quality Control.
• Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, JMP, minitab, etc.).