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Job: QC Specialist Stability Coordinator, Medicago USA, DURHAM, NC
QC Specialist Stability Coordinator
DURHAM, NC 27713 United States
Documentation & Technical Writing
Manufacturing and Production
Under the supervision of a QC Manager, the candidate is responsible for the coordination and execution of activities for the stability program within quality control programs including the following responsibilities:
• Maintain and grow the QC stability program while adhering to all Medicago policies and procedures
• Creating stability study protocols, setting up studies, coordinating testing, evaluating results and generating a final report.
• Act as subject matter expert for regulatory guidance on stability programs
• Author/review SOPs related to the QC Support program
• Track, trend, and review data produced in support of ongoing stability studies
• Perform statistical analysis of data to ensure that all policies, trends, and specifications are maintained throughout stability studies
• Manage testing as it relates to timepoints to ensure that all requirements are met
• Author and lead investigations as needed according to all Medicago policies and procedures
• Lead change efforts through change controls and CAPAs in collaboration with QA and other impacted departments
• Perform laboratory testing as required
• Aseptically handle samples to be tested at approaching timepoints
• Provide oversight of the stability program for generating the data to justify beyond-use-dates
• Working knowledge of requirements and best practices necessary to maintain cGMP laboratory environment
• Understanding of statistical analysis programs (i.e. JMP, Minitab)
• Experience with stability studies and general program management
• Must have the ability to multitask in a fast paced environment
• Proficiency with Microsoft Office suite applications (Excel and Word preferred)
• Self-starter, results oriented individual with ability to organize and analyze data
• Understanding basic analytical assays and microbiological methods preferred
• Proactively looks for opportunities to identify change, increase efficiency, influence decisions and deliver results while ensuring compliance.
• Bachelor’s degree in scientific field with a minimum of 4 years of experience within Biotech industry
o Experience managing stability program preferred
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North Carolina Biotechnology Center