Microbiologist
About this role
Company Description
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 test methods 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:
· Performing lab tests in the areas of bacteriology, mycology, mycobacteriology
· Performs environmental monitoring of plant utilities and production clean zones using particle counters, contact plates and microbial air samplers
· 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
· Participate in aseptic processing in a clean room environment
· 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
· Perform protocol driven studies for bioburden, endotoxin, , EM, Raw Materials -ID, etc.
· Generating data to support site manufacturing and/or complaint investigations and resolving project-related questions
· Manage variable sample influx by potentially adjusting daily schedule
· Communicate expected sample test times and results with QC Lab Assistants
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)
· Aseptic technique or cleanroom experience desired
· Organism identification experience a plus
· 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
Qualifications
· 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 desirabl
Additional Information
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