Microbiologist

Mindlance is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at http://www.mindlance.com. Job Description: We are seeking a highly motivated QC Microbiologist who is interested in joining our fast-paced, dynamic QC environment to perform microbiological sampling in support of Facility Utilities Monitoring and Environmental Monitoring Program in support of the GMP manufacturing facility of a cell therapy product including sampling of raw material and release testing. Duties & Responsibilities • Sampling Lead – Utililities, gases, EM and Raw Materials • Submit micro identifications to CRO • Responsible for daily scheduling of junior analyst sampling schedule • Manage variable sample influx by potentially adjusting daily schedule • Communicate expected sample test times and results with QC Lab Assistants • Participate in aseptic processing in a clean room environment • Performs environmental monitoring sampling of plant utilities and production clean zones using particle counters, contact plates and microbial air samplers • Perform protocol driven studies for bioburden, endotoxin, , EM, Raw Materials -ID, etc • Report testing results via Laboratory Inventory Management System (LIMS) • Generating data to support site manufacturing and/or complaint investigations and resolving project-related questions • Performs routine and non-routine microbiological testing such as water bioburden and media growth promotion; Gram staining and microbial identifications • Performs enumeration and characterization of microorganisms recovered from samples • Perform growth promotion • Identifies bacteria and susceptibilities, molds, yeast, parasites, and other related organisms • Perform Microbiological test methods for cell therapy product, raw material and release testing Minimum Requirements • B.S. in Biology/Microbiology, or related sciences with 3-5 years of related experience. • Previous working experience in a QC laboratory GMP manufacturing facility highly desirable • Strong time management and organization skills are required • Knowledge of regulatory requirements and standards (FDA, EU, ICH, ISO, USP) a plus • Aseptic technique or cleanroom experience desired • The ability to work off-shift hours, based on business needs, is required • Able to work independently with minimum supervision • Good accurate and clear documentation skills is required Minimum Requirements • B.S. in Biology/Microbiology, or related sciences with 3-5 years of related experience. • Previous working experience in a QC laboratory GMP manufacturing facility highly desirable • Strong time management and organization skills are required • Knowledge of regulatory requirements and standards (FDA, EU, ICH, ISO, USP) a plus • Aseptic technique or cleanroom experience desired • The ability to work off-shift hours, based on business needs, is required • Able to work independently with minimum supervision • Good accurate and clear documentation skills is required All your information will be kept confidential according to EEO guidelines.