• Provide scientific support for project teams.
• Coordinate sample shipment and purchase orders for outsourced testing.
• Perform data entry using LIMS system.
• Support facilities through environmental monitoring.
• Assist with implementation of modern microbiology methods and technology.
• Co-ordinate microbiological testing of samples for clinical manufacture.
• Perform microbiological testing of EM samples.
• Enter microbiological test results from in house or contract microbiological testing labs.
• Review microbiological results for completeness, accuracy, and quality, in addition to assessing trends to draw conclusions.
• Work with UP microbiology team to define microbiological control strategies for drug products (both API and Formulations).
• Transcription checking or review of microbiology data and submissions.
• Maintain partnerships with clinical manufacturing and product development teams to provide timely and high-quality data and service.
• Bachelor’s degree in a scientific or technical discipline
• General compendial knowledge of USP Microbiology.
• Experience with GMP laboratory operations and FDA regulations.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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