What are the responsibilities and job description for the Quality Control Microbiologist position at United Pharma Technologies Inc?
Job Title: QC Microbiologist
Location: New Jersey
Job Summary:
We are seeking a skilled QC Microbiologist with hands-on experience in Laboratory Information Management Systems (LIMS) to join our Quality Control team in New Jersey. The ideal candidate will be responsible for conducting microbiological testing, ensuring compliance with regulatory requirements, and effectively managing data within LIMS. This role requires expertise in microbiological techniques, GMP regulations, and laboratory automation.
Key Responsibilities:
- Perform microbiological testing on raw materials, in-process samples, finished products, and environmental monitoring samples.
- Utilize LIMS for data entry, analysis, and reporting of microbiological results.
- Conduct sterility, endotoxin, bioburden, microbial identification, and growth promotion testing.
- Ensure compliance with GMP, FDA, USP, EP, and other regulatory standards.
- Support environmental monitoring programs, including air, water, and surface sampling.
- Investigate out-of-specification (OOS) and out-of-trend (OOT) results and participate in root cause analysis.
- Collaborate with cross-functional teams to support quality improvement initiatives.
- Maintain laboratory equipment, calibrations, and validations.
- Assist in writing and reviewing SOPs, protocols, and technical reports.
- Train junior staff on microbiological techniques and LIMS usage.
Qualifications & Requirements:
- Bachelor’s or Master’s degree in Microbiology, Biology, or a related field.
- Minimum of 3 years of experience in a pharmaceutical or biotechnology QC microbiology laboratory.
- Hands-on experience with LIMS, preferably in a GMP-regulated environment.
- Strong knowledge of microbiological testing methods (e.g., sterility, endotoxin, microbial limits).
- Familiarity with USP, EP, JP, FDA, and ICH guidelines.
