Job Details

Description

• Develop standard operating procedures (SOPs) study-specific procedures (SSP), and other relevant study documentation to ensure compliance with Good Laboratory Practices (GLP) regulation
• Impart and shares knowledge through inlab training and side-by-side work for the transmittal of regulatory concepts, practices, and procedures
• Perform laboratory quality management activities for supported customers to the required quality standard, , GLP
• Support the SIP Program by assisting GLP compliant studies for potency testing of clinical research materials
• Will be expected to work in biocontainment environments (i.e., BSL-2, -3, and BSL-4, as needed), and meet requirements under the Army Personnel Reliability Program
• Working in conjunction with a project manager, coordinates project team member activities to achieve common objectives monitors project plans and tracks project status, issues and progress
• Implements, modifies, tests and administers laboratory system applications
• Assess user needs and recommends modifications
• Develops modification, recommendations and changes for systems, technologies, and customer support processes
• Gather requirements, build, and test and implement solutions for laboratory applications

• BS degree in a biomedical science with a minimum of 9 yrs
• MS with a minimum of 4 yrs
• Will be expected to work in biocontainment environments (i.e., BSL-2, -3, and BSL-4, as needed), and participation in the biological personnel reliability program is required.   
• Previous QC laboratory experience, including gas and liquid chromatography (preferred)
• Previous experience in cGMP atmosphere (preferred)
• Years of Laboratory Information Systems experience