Specialist Quality Control 35202

Under general direction, functions as the 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.

• Scientific Data Analysis
• Strong Technical Writing (English and Spanish) mainly focuses
• Strong knowledge in Microsoft Excel as a Tool for Data Analysis
• Good Communication skills
• Project Management
• Sample Management
• Knowledge in Computer System and Method Validation (Experience preferable)
• Strong knowledge and experience with quality process management
• Basic Knowledge on equipment preventive maintenance and troubleshooting
• Agile on prioritization of critical tasks
• Ability to develop inspection or qualification protocols in a short timeframe period.
• Strong negotiation skills

• 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.
• May perform routine work in a specific area of responsibility as necessary.
• 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.
• May resolve issues with outside resources.
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• Doctorate or Masters + 2 years of directly related experience or Bachelors + 4 years of directly related experience or Associates + 8 years of directly related experience or High school/GED + 10 years of directly related experience.
• Preferable Scientific Background (Science or Engineering) with experience in Pharmaceutical Industry, Quality Control, Laboratory Testing, Project Management Method Validation, Method Transfer and Quality processes. Preferable experience as Microbiologist, Chemist, Biochemistry, Molecular Sciences, or Chemical Engineering.