Senior QC Microbiologist - Subject Matter Expert

Eurofins PSS; Exton (Chester County); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company is seeking a Senior QC Microbiologist to serve as a Subject Matter Expert in microbiology for pharmaceuticals. This full-time role involves training staff, conducting testing, and ensuring compliance with quality control standards. The ideal candidate will have extensive experience in microbiology, particularly in GMP environments, and will be responsible for various laboratory activities and maintaining data integrity.

Benefits

Comprehensive benefits including medical, dental, and vision

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Yearly bonus and merit increases

Qualifications

• Minimum of 4 years microbiology experience in GMP biologics or pharmaceutical environments.
• Expertise in BacT rapid sterility assay, endotoxin testing, and environmental monitoring.

Responsibilities

• Performing sterility, endotoxin, pH, and osmolality testing on raw materials.
• Leading aseptic processing media fills and performing support testing.
• Responding to Out of Specification results and implementing CAPAs.

Skills

Sterility and Endotoxin testing

USP standards

Growth promotion

Environmental monitoring

Aseptic process media fills

cGMPs

Excellent communication skills

Education

BS in a related scientific discipline

Tools

microscopes

pH meters

incubators

Job description

Senior QC Microbiologist - Subject Matter Expert

Eurofins PSS is looking for a Subject Matter Expert (SME) in QC Microbiology for pharmaceuticals. The highly experienced employee will work at a client site as the only experienced staff member, serving as the point of contact for all microbiology-related quality control activities in the lab. Responsibilities include training staff, updating processes, conducting testing, and investigating non-conformances.

The qualified individual MUST be an expert in:

• Sterility and Endotoxin testing
• USP standards
• Growth promotion, gram staining
• Environmental monitoring of pharmaceutical labs and manufacturing spaces
• Aseptic process media fills
• cGMPs

Key activities include:

• Performing sterility, endotoxin, pH, and osmolality testing on raw materials, drug substances, and drug products
• Conducting gram stains, sub-culturing isolates, growth promotion testing, and cell culture
• Coordinating and executing testing based on manufacturing schedules
• Leading aseptic processing media fills and performing support testing, including visual inspections
• Maintaining laboratory housekeeping and equipment logs
• Supporting daily QC operations
• Authoring and revising SOPs and change controls
• Authoring and executing qualification protocols and reports
• Responding to Out of Specification (OOS) results, investigating, and implementing CAPAs
• Ensuring data integrity following Good Documentation Practices and ALCOA++ principles
• Troubleshooting nonconforming data and conducting thorough investigations
• Performing internal audits and GEMBA walk-throughs
• Communicating with Operations departments to meet objectives
• Supporting environmental monitoring inside aseptic clean rooms
• Overseeing critical manufacturing steps during aseptic production
• Training staff as needed

BASIC MINIMUM REQUIREMENTS:

• BS in a related scientific discipline
• Minimum of 4 years microbiology experience in GMP biologics or pharmaceutical environments
• Expertise in BacT rapid sterility assay, endotoxin testing, growth promotion, media fills, and environmental monitoring; cell therapy experience preferred
• Knowledge of cGMP, GMP documentation, and industry standards
• Experience with aseptic processing and mammalian cell culture
• Familiarity with laboratory equipment such as microscopes, pH meters, incubators
• Excellent communication skills
• Availability for occasional off-shift and weekend work
• Ability to work independently and train others

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

What we offer:

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

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