Microbiologist

Mindlance; 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.
• Perform environmental monitoring and testing using culture methods and LIMS.
• Generate data to support manufacturing and investigations.

Skills

Strong time management and organization skills

Clear documentation skills

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

Ability to work independently

Regulatory knowledge

Education

B.S. in Biology/Microbiology or related sciences

Tools

LIMS

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.