Job Title: Senior GMP Microbiologist
Location: Mundelein, IL
Duration: 6 Months
Rate: $60 - $65/hr W2
Experience: 10+ Years
Position Overview:
We are seeking an experienced Senior GMP Microbiologist to conduct a comprehensive assessment of an in-house Quality Control microbiology laboratory supporting product release and environmental monitoring activities across multiple manufacturing sites.
The ideal candidate will have strong pharmaceutical microbiology experience, with expertise in GMP laboratory operations, environmental monitoring, microbiological testing, method validation, data integrity, laboratory investigations, and regulatory compliance. The consultant will evaluate laboratory processes, procedures, testing methods, equipment, documentation, and quality systems and provide practical remediation recommendations.
Key Responsibilities:
- Assess microbiology laboratory operations against FDA cGMP requirements, USP requirements, internal procedures, and industry best practices
- Evaluate laboratory organization, staffing, training, analyst qualifications, supervision, and Quality Unit oversight
- Review microbiological testing supporting product release, raw materials, utilities, and environmental monitoring
- Evaluate microbial enumeration, specified microorganism testing, bioburden testing, and microbial identification
- Assess media preparation, growth-promotion testing, media storage, culture maintenance, and reference organism controls
- Evaluate microbiological method validation, verification, suitability, and method transfer activities
- Review laboratory equipment qualification, calibration, preventive maintenance, and operational controls
- Assess sample handling, storage, testing, retention, and disposition processes
- Evaluate data integrity, audit trails, electronic records, and Good Documentation Practices
- Review deviations, OOS/OOT results, contamination events, environmental monitoring excursions, and CAPA activities
- Identify compliance gaps, operational weaknesses, and areas for improvement
- Develop risk-based remediation strategies and laboratory improvement recommendations
- Prepare assessment reports and communicate findings to Quality, laboratory management, and site stakeholders
- Support regulatory inspections, laboratory audits, and remediation activities as needed
Required / Preferred Qualifications:
- Bachelor's degree or higher in Microbiology, Biology, Biological Sciences, or a related scientific discipline
- 10+ years of pharmaceutical, biotechnology, or regulated microbiology laboratory experience
- Strong GMP Quality Control microbiology laboratory experience
- Experience supporting pharmaceutical product release and manufacturing operations
- Hands-on experience with environmental monitoring, bioburden, microbial enumeration, and microbial identification
- Experience with microbiological method validation, verification, suitability, and method transfer
- Experience investigating microbial excursions, contamination events, OOS/OOT results, and laboratory deviations
- Experience with laboratory audits, GMP assessments, or regulatory inspections is strongly preferred
- Laboratory leadership, technical lead, management, or SME experience is preferred
- Knowledge of FDA 21 CFR Parts 210 & 211 and GMP laboratory controls
- Knowledge of USP < 61>, < 62>, < 1111>, < 1115>, and < 1116> is preferred
- Strong understanding of Data Integrity, ALCOA+, GDP, CAPA, deviations, and root-cause analysis
- Strong technical writing, communication, and analytical skills