Principal QC Microbiologist

Principal QC Microbiologist

Location: Brentwood, MO (Onsite)
Assignment: 6-Month Contract with Potential to Extend or Convert to Permanent
Pay Rate: $66/hour

Position Summary

We are seeking an experienced Principal QC Microbiologist to provide technical leadership and oversight of Quality Control Microbiology laboratory operations within a GMP-regulated pharmaceutical manufacturing environment. This role will oversee microbiological testing, data review, investigations, method validation, and regulatory compliance while supporting laboratory improvements and mentoring junior team members.

Key Responsibilities

• Provide technical oversight and hands-on support for microbiological testing, including endotoxin, bioburden, microbial identification, and environmental monitoring.

• Review and approve laboratory data, ensuring compliance with cGMP, GDP, and applicable regulatory standards.

• Author, review, and approve SOPs, protocols, specifications, validation reports, and technical documentation.

• Lead OOS investigations, deviations, root cause analysis, and CAPA activities.

• Support microbiological method development, validation, verification, and transfer.

• Provide technical guidance, training, and mentorship to laboratory personnel.

• Support aseptic processing, contamination control, and manufacturing quality initiatives.

• Drive continuous improvement projects to enhance laboratory efficiency, compliance, and testing capabilities.

Required Qualifications

• Bachelor's degree in Microbiology, Biology, Biochemistry, or a related scientific discipline.

• Minimum 7 years of QC Microbiology experience in pharmaceutical or biotechnology laboratories.

• Hands-on experience with endotoxin, bioburden, microbial identification, and environmental monitoring.

• Strong knowledge of cGMP and regulatory requirements, including USP, EP, ICH, and EU Annex 1.

• Experience with microbiological method validation, verification, and transfer.

• Demonstrated experience with laboratory investigations, deviations, OOS, and CAPA.

• Strong technical writing, communication, and documentation skills.

• Ability to provide technical leadership in a hands-on laboratory environment.

Preferred Qualifications

• Experience supporting pharmaceutical development and commercial manufacturing.

• Background in CDMO, biologics, or multi-product manufacturing environments.

• Experience with MODA environmental monitoring software.
  
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