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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.