Quality Control Microbiologist
Quality Control Microbiologist
See who Kelly Science, Engineering, Technology & Telecom has hired for this role
Job Title: Senior Scientist, Microbiology
Job Description: We are seeking a highly skilled Senior Scientist specializing in Microbiology to lead and actively participate in the experimental design, method validation/qualification, and technical transfer activities for compendial methods across raw materials and finished products. As a pivotal member of our Quality Control team, you will perform both routine and non-routine testing, ensuring adherence to cGMP guidelines and leveraging lean six sigma principles for continuous improvement.
Key Responsibilities:
- Lead experimental design, compendia method qualifications, and assay transfers to ensure seamless project execution in the laboratory.
- Execute a variety of microbiological methods including Bioburden testing, Sterility Testing, and Microbial Limits Testing.
- Manage the stability program from sample pulling through testing, submission to external labs, and report generation.
- Train new hires and assist junior analysts in water and environmental sampling, gown qualification, and media fills.
- Oversee environmental performance qualifications for new cleanroom areas, conducting risk assessments and developing sampling plans.
- Analyze and interpret results, ensuring accuracy, completeness, and compliance with regulatory requirements.
- Configure new analyses, products, and specifications in LIMS, liaising with vendors for laboratory needs.
- Author and review GMP data, including SOPs, test methods, validation protocols/reports, and technical reports.
- Monitor lifecycle of microbiology instruments, ensuring calibration and maintenance conform to specifications.
- Manage QC document archival and inventory control of consumables, media, and garments.
- Issue deviations, conduct laboratory investigations, and implement corrective actions in LIMS and QA-Track.
- Develop and deliver training programs for junior analysts and Micro Associates on technical concepts and methods.
Requirements:
- Bachelor of Science Degree in Biological or Environmental Sciences required; Master of Science degree preferred.
- Minimum 8 years of QC laboratory experience in pharmaceutical or biopharmaceutical industry with Bachelor's Degree, or 4 years with Master's degree.
- Strong preference for experience in Cell/Gene Therapy, Cell-Based Assays, and Rapid Microbial Methods.
- Expertise in SOPs, analytical test methods, and laboratory practices.
- Knowledge of USP/EP/cGMP and ICH guidelines, microbiology techniques, and LIMS.
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Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Research and Science -
Industries
Pharmaceutical Manufacturing
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See who you knowFeatured Benefits
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Medical insurance -
Dental insurance -
Vision insurance -
401(k) -
Pension plan -
Disability insurance
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