JT982 - SPECIALIST QUALITY CONTROL
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Responsibilities:
• Technical specialist for testing and development in areas of molecular biology and microbiology.
• Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources.
• Responsible for providing technical guidance, Provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise
• Resolve technical issues and troubleshoot for assays as necessary
• Ensure lab compliance which includes: Implementing procedures that enhance GMP, GLP and safety.
• Manage existing and/or develop and implement new programs, processes and methodologies
• Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.
• Approve lab investigations, Lead audit teams
• May serve as subject matter expert to develop technical training
• Represents the department/organization on various teams, Independently responsible for following through on multi-site action items
• May interact with regulatory agencies regarding area(s) of responsibility including written responses
Qualifications:
• Bachelors' Degree in Science (Preferred: Background Microbiology)
• Technical Writing for Microbiology Method Validations reports for new product introductions
• Knowledge in Bioburden , Endotoxin , Low endotoxin recoveries , Sterility testing , MMV and Mycoplasma testing
• Provide Technical support to the microbiology lab
• Design special studies
• Support Deviation records owners as evaluating events and root cause
• Administrative Shift
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