Senior QC Microbiologist - Subject Matter Expert

Eurofins PSS Insourcing Solutions; Exton (Chester County); On-site; USD 60,000 - 95,000; Full time

Job summary

An established industry player is seeking a Senior QC Microbiologist to join their dynamic team. In this pivotal role, you will leverage your expertise in microbiology to ensure product safety and compliance within the biopharmaceutical sector. Your contributions will directly impact the quality of essential products that enhance health and safety globally. This position offers a supportive environment focused on professional growth, work-life balance, and a competitive benefits package. If you are passionate about making a difference in the life sciences, this opportunity is perfect for you.

Benefits

Comprehensive medical coverage

Dental and vision options

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Yearly goal-based bonus

Eligibility for merit-based increases

Qualifications

• 4+ years of microbiology experience in GMP biologics or pharmaceutical environments.
• Subject matter expert in BacT rapid sterility assay and endotoxin testing.

Responsibilities

• Perform sterility, endotoxin, pH, and osmolality testing on drug products.
• Author and revise QC SOPs and execute qualification protocols.

Skills

Microbiology

Aseptic Processing

Environmental Monitoring

Good Manufacturing Practice (GMP)

Documentation Practices

Communication Skills

Education

Bachelor's degree in a related scientific discipline

Tools

Microscopes

pH Meters

Incubators

Job description

Senior QC Microbiologist - Subject Matter Expert

The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we focus on your professional growth and provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier, and more sustainable. From the food you eat to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure product safety and compliance.

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

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 as necessary to maintain compliance.
• Author and execute qualification protocols and reports for microbiological assays.
• Perform timely response to Out of Specification (OOS) results, including notification to area management and documentation of laboratory investigations.
• Ensure data integrity is maintained for all applications, programs, and executed work.
• Troubleshoot and analyze nonconforming data, completing thorough investigations.
• Perform internal audits and GEMBA walk-throughs of laboratory areas to maintain compliance.
• Communicate with individual Operations Departments to ensure Company objectives are met on schedule.
• Perform viable and non-viable environmental monitoring in support of Manufacturing and Quality Control.
• Oversight of critical processing steps performed by Manufacturing during aseptic product manufacture.
• Training of other employees as necessary.

QualificationsBASIC MINIMUM REQUIREMENTS:

• BS in a related scientific discipline.
• At least 4 years of microbiology experience in a GMP biologics or pharmaceutical environment.
• Subject matter expert with BacT rapid sterility assay, endotoxin testing, growth promotion, aseptic process media fills, and environmental monitoring required.
• Knowledge of Current Good Manufacturing Practice, Good Documentation Practices, and Industry standards required.
• Experience in aseptic processing and mammalian cell culture production.
• Familiarity with basic laboratory equipment such as microscopes, pH meters, incubators.
• Excellent verbal and written skills with good interpersonal communication skills.
• Must be open to occasional off shift and weekend work.
• Must be able to work independently and train others as needed.

Additional Information

Position is Full Time, Monday – Friday First Shift with support outside of standard hours. Candidates currently living within a commutable distance of Exton, PA are encouraged to apply.

What we offer:

• Excellent full-time benefits including comprehensive medical coverage, dental, and vision options.
• Life and disability insurance.
• 401(k) with company match.
• Paid vacation and holidays.
• Yearly goal-based bonus & eligibility for merit-based increases.

Eurofins USA PSS Insourcing Solutions is an M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.