Research and Development
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Job: Quality Assurance Senior Specialist, Medicago USA, Durham, NC
Quality Assurance Senior Specialist
Durham, NC 27709 United States
Research and Development
Under the supervision of Quality Operations Supervisor, the candidate is responsible for the execution of activities for assigned tasks within quality assurance programs. Responsibilities include performing as the lead resource in the implementation and management of the day-to-day lifecycle of batch review/disposition. Responsibilities include performing as the QA resource in the ERP implementation and provide superuser support for QA group. Provide support for other Quality Systems such as GMP Material Disposition and Quality Events including deviations, CAPA and Change Control.
• Primarily responsible for the Quality programs/systems governing batch record review and disposition for product release and ensure required documentation is complete.
• Provide support to ERP implementation team and serve in an ongoing role as superuser for the QA group.
• Complete area impact assessments for change controls for QA Operations. Ensure that associated investigations and change controls are approved by Quality Assurance. Complete required documentation for the review process in accordance with established procedures.
• Perform QA review of validation protocols and reports, including reviewing and approving manufacturing and QC records
• Provide production shop floor support as needed for manufacturing and laboratory processes, records, and equipment.
• Perform review of deviations, CAPA, and Calibration Exception Reports, and environmental alert/actions records. Follow up on all issues to assure each is addressed appropriately. Coordinate needed quality event record corrections with production/QC/facility management. Ensure required documentation is complete and attached to the record.
• Author and review SOPs as required. Review and approve Master Production Record revisions.
• Provide support for the GMP materials program by performing disposition activities for incoming GMP production materials.
• Pharmaceutical manufacturing, packaging, or laboratory experience including at least 7 years in GMP QA/QC/Compliance.
• Strong knowledge of Nonconformance/Deviation, CAPA and Change Control programs with expertise in scientific technical writing and reviewing of documentation for these processes.
• Experience with material disposition utilizing an ERP system (e.g. SAP, JDE, 365 Microsoft Dynamics, etc.) Experience with setting up Master Data in ERP system.
• Demonstrated expertise with the application of quality assurance systems & regulatory subject matter for batch review and disposition.
• Demonstrated ability to analyze and communicate quality event program status and issues in Senior Management forums.
• Must be an organized results oriented self-starter with attention to detail and have the ability to independently and efficiently multitask in a fast paced environment with excellent communication skills (both written and oral).
• Experience with MS Office & enterprise applications (example: MasterControl, LIMS, Trackwise, etc.) preferred.
• While performing the duties of this job, the employee is regularly required to sit and use hands to type or handle various items. The employee is occasionally required to stand, walk, reach or stoop. The employee must occasionally lift and/or move up to 20 pounds.
• Requires a Bachelor’s degree in science or engineering and 7 or more years of biopharmaceutical experience. An associate degree and 9 years of biopharmaceutical industry experience will also be considered.
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