Microbiologist
Integrated Resources Inc
Microbiologist Following is the position details: Title: Microbiologist - Permanent Position Location: West Chester, PA. 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 – Utilities, 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
- 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
Vacancy posted 3 days ago
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