QC Microbiologist – GMP Cell Therapy & EM

Mindlance, Inc.; West Chester (Chester County); On-site; USD 65,000 - 90,000; Full time

Job summary

A national recruiting company is seeking a highly motivated QC Microbiologist to join a dynamic QC environment in Chester County, West Chester. This role involves performing microbiological sampling related to GMP manufacturing, managing sample schedules, and conducting tests in a clean room. Candidates should possess a B.S. in Biology or Microbiology and 3-5 years of related experience, preferably in a QC laboratory within a GMP setting. Strong time management and documentation skills are essential.

Qualifications

• 3‑5 years of related experience in a QC laboratory.
• Experience in GMP manufacturing facility highly desirable.
• Ability to work off‑shift hours as required.

Responsibilities

• Perform microbiological sampling in support of the GMP manufacturing facility.
• Manage variable sample influx and daily schedules.
• Participate in aseptic processing in a clean room environment.

Skills

Strong time management and organization skills

Clear documentation skills

Knowledge of regulatory requirements (FDA, EU, ICH, ISO, USP)

Ability to work independently

Education

B.S. in Biology/Microbiology or related sciences

Job 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

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

• 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

• 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

• 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 desirable

• Strong time management and organization skills are required

• Knowledge of regulatory requirements and standards (FDA, EU, ICH, ISO, USP) 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

Additional Information

All your information will be kept confidential according to EEO guidelines.

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