Principal QC Microbiologist

Eurofins USA PSS Insourcing Solutions; Exton (Chester County); On-site; USD 60,000 - 90,000; Full time

Job summary

An established industry player is seeking a dedicated microbiologist to join their team. This full-time position involves performing critical testing on raw materials and drug products, ensuring compliance with industry standards. You will play a key role in maintaining data integrity and supporting quality control operations. The ideal candidate will have a strong background in microbiology, particularly in aseptic processing and environmental monitoring. This is a fantastic opportunity to contribute to a forward-thinking company that values innovation and quality in the pharmaceutical sector.

Benefits

Comprehensive medical, dental, and vision benefits

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Yearly goal-based bonus

Merit-based increases

Qualifications

• 4+ years of microbiology experience in a GMP biologics or pharmaceutical environment.
• Expertise in BacT rapid sterility assay and endotoxin testing.
• Familiarity with environmental monitoring and cell therapy.

Responsibilities

• Perform sterility, endotoxin, pH, and osmolality testing on various materials.
• Coordinate and execute testing based on manufacturing schedules.
• Maintain data integrity and compliance with Good Documentation Practices.

Skills

Microbiology

Aseptic Processing

Environmental Monitoring

Good Manufacturing Practice (GMP)

Good Documentation Practices

Communication Skills

Education

Bachelor's Degree in a related scientific discipline

Tools

Microscopes

pH Meters

Incubators

Job description

Job Description

• Perform sterility, endotoxin, pH, and osmolality testing on raw materials, drug substance, and drug product.
• Perform gram stains, sub-culturing of isolates, growth promotion testing, and general cell culture.
• Coordinate, schedule, and execute testing based on manufacturing schedules.
• Direct performance in Aseptic Processing Media Fills and perform support testing, including visual inspection.
• Maintain housekeeping and equipment maintenance, including organization, cleanliness, and logbooks.
• Assist the Quality Control department in daily operations as needed.
• Author and revise QC SOPs and change controls to maintain compliance.
• Author and execute qualification protocols and reports for microbiological assays.
• Respond promptly to Out of Specification (OOS) results, including notification to management, and perform laboratory investigations to identify root causes, assess impact, and implement corrective actions (CAPA).
• Maintain data integrity for all applications, programs, and work performed, adhering to Good Documentation Practices and ALCOA++ principles.
• Troubleshoot and analyze nonconforming data, conduct thorough investigations, and implement preventive actions.
• Perform internal audits and GEMBA walk-throughs of laboratory areas to ensure compliance.
• Communicate with Operations Departments (Manufacturing, Quality Assurance, Facilities) to meet company objectives on schedule.
• Conduct environmental monitoring (air, surface, personnel, particulate) inside aseptic clean rooms to support Manufacturing and Quality Control.
• Oversee critical processing steps performed by Manufacturing during aseptic product manufacture to ensure accuracy.
• Train other employees as necessary.

Qualifications:

• BS in a related scientific discipline.
• At least 4 years of microbiology experience in a GMP biologics or pharmaceutical environment.
• Expertise in BacT rapid sterility assay, endotoxin testing, growth promotion, aseptic process media fills, and environmental monitoring; experience with cell therapy is preferred.
• Knowledge of Current Good Manufacturing Practice, Good Documentation Practices, and industry standards.
• Experience in aseptic processing and mammalian cell culture production.
• Familiarity with basic laboratory equipment such as microscopes, pH meters, incubators.
• Excellent verbal and written communication skills.
• Availability for occasional off-shift and weekend work.

Additional Information

This is a full-time position, Monday – Friday, first shift, with support outside of standard hours. Candidates living within a commutable distance of Exton, PA are encouraged to apply.

What we offer:

• Comprehensive medical, dental, and vision benefits.
• Life and disability insurance.
• 401(k) with company match.
• Paid vacation and holidays.
• Yearly goal-based bonus and merit-based increases.

Eurofins USA PSS Insourcing Solutions is an Equal Employment Opportunity employer, supporting Disabled and Veteran applicants.