Senior QC Microbiologist

Eurofins 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 in Exton, PA. This full-time position offers a unique opportunity to engage in critical testing and quality control processes within a supportive environment. You will perform essential microbiological assays, ensuring compliance with industry standards while contributing to the safety and efficacy of biopharmaceutical products. With a focus on professional growth, this role promotes work-life balance and offers a competitive benefits package, including comprehensive health coverage and a 401(k) plan. If you are passionate about making a difference in the biopharmaceutical industry, this is the perfect opportunity for you.

Benefits

Comprehensive Medical, Dental, and Vision Benefits

Life and Disability Insurance

401(k) with Company Match

Paid Vacation and Holidays

Yearly Bonuses and Merit Increases

Qualifications

• 4+ years of microbiology experience in GMP biologics or pharmaceutical environments.
• Knowledge of GMP, GxP, and industry standards required.
• Experience with BacT rapid sterility assay and endotoxin testing preferred.

Responsibilities

• Perform sterility, endotoxin, pH, and osmolality testing on raw materials and drug products.
• Coordinate and execute testing in accordance with manufacturing schedules.
• Respond to Out of Specification results and implement corrective actions.

Skills

Microbiology Experience

Aseptic Processing

Environmental Monitoring

Good Documentation Practices

Communication Skills

Education

Bachelor's Degree in a Related Scientific Discipline

Tools

Laboratory Equipment (Microscopes, pH Meters, Incubators)

Job description

2 weeks ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we focus on your professional growth. We provide opportunities to break into the biopharmaceutical industry and advance from the bottom up. Our supportive teams and tools are available to invest in your development while promoting work-life balance and offering a competitive benefits package.

Eurofins Scientific is an international life sciences company providing a wide range of analytical testing services across multiple industries to make life and our environment safer, healthier, and more sustainable. We work with major companies to ensure the safety, authenticity, and accurate labelling of products you rely on daily, including food, water, and medicines. Eurofins is a global leader in food, environmental, pharmaceutical, and cosmetics testing, as well as in genomics, discovery pharmacology, forensics, CDMO, advanced material sciences, and clinical studies support.

If you’re seeking a rewarding career and a place to call home, apply with us today!

Job Description

• Perform sterility, endotoxin, pH, and osmolality testing on raw materials, drug substances, and drug products.
• Conduct gram stains, isolate sub-cultures, perform growth promotion testing, and general cell culture.
• Coordinate, schedule, and execute testing in accordance with manufacturing schedules.
• Lead aseptic processing media fills and support testing, including visual inspections.
• Maintain cleanliness, organize equipment, and keep detailed logbooks.
• Assist the Quality Control department in daily operations as needed.
• Write and update QC SOPs and change controls to ensure compliance.
• Develop and execute qualification protocols and reports for microbiological assays.
• Respond promptly to Out of Specification (OOS) results, notify management, investigate issues, and implement CAPA.
• Ensure data integrity following Good Documentation Practices and ALCOA++ principles.
• Troubleshoot nonconforming data, perform investigations, and implement corrective actions.
• Conduct internal audits and GEMBA walk-throughs to maintain compliance.
• Communicate with Operations, Manufacturing, QA, and Facilities to meet company objectives.
• Perform environmental monitoring in aseptic areas, including air, surface, personnel, and particulate testing.
• Oversee critical manufacturing steps during aseptic production to ensure accuracy.
• Train other employees as necessary.

Qualifications

BASIC MINIMUM REQUIREMENTS:

• Bachelor's degree in a related scientific discipline.
• At least 4 years of microbiology experience in GMP biologics or pharmaceutical environments.
• Experience with BacT rapid sterility assay, endotoxin testing, growth promotion, aseptic media fills, and environmental monitoring; cell therapy experience preferred.
• Knowledge of GMP, GxP, and industry standards.
• Experience in aseptic processing and mammalian cell culture production.
• Familiarity with laboratory equipment such as microscopes, pH meters, incubators.
• Excellent communication skills, both verbal and written.
• Availability for occasional off-shift and weekend work.

Additional Information

Position is full-time, Monday–Friday, first shift, with support outside 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 bonuses and merit increases.

Eurofins USA PSS is an Equal Employment Opportunity employer, supporting diversity and inclusion.