- Job Purpose
• 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.
• Ensure data meets compendial and companies quality Standards.
• 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).
• Support rapid microbiology technology evaluations in relevant areas to support Sterility testing, Environmental Monitoring, and Endotoxin testing.
• 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.
• Support project teams through clinical progression helping to deliver validated microbiological testing procedures.
• Maintain training records and familiarity with current SOPs and controlled documents.
• Proactively seek assistance from other scientists to solve problems.
• Work to GMP standards as appropriate.
• Follow safe Laboratory Practices, regular safety training, and maintain accurate and complete safety records consistent with company policy and legal requirements.
• Bachelor’s degree in a scientific or technical discipline (i.e. Pharmaceutical Sciences, Microbiology, Biology) with preference to having experience with routine bioburden and endotoxin testing, and method development/qualification.
• General compendial knowledge of USP Microbiology.
• Experience with GMP laboratory operations and FDA regulations.
• Excellent verbal and written communication skills
• Ability to prioritize and organize tasks.
• A high level of learning agility.
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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