Senior QC Microbiologist

Eurofins USA; Exton (Chester County); On-site; USD 50,000 - 85,000; Full time

Job summary

An established industry player is seeking a dedicated microbiologist to join their team in Exton. In this vital role, you will perform critical testing to ensure the safety and efficacy of biopharmaceutical products. You will be part of a supportive environment that emphasizes professional growth and offers a competitive benefits package. The position involves coordinating testing schedules, maintaining compliance, and contributing to a culture of quality and integrity. If you are passionate about making a difference in the biopharmaceutical industry, 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 a GMP biologics or pharmaceutical environment.
• Knowledge of GMP and Good Documentation Practices is essential.

Responsibilities

• Perform sterility, endotoxin, and pH testing on raw materials and drug products.
• Assist Quality Control in daily operations and maintain compliance.

Skills

Microbiology

Good Manufacturing Practice (GMP)

Good Documentation Practices

Aseptic Processing

Environmental Monitoring

Cell Culture

Communication Skills

Education

BS in a related scientific discipline

Tools

Microscopes

pH Meters

Incubators

Job description

The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the 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 water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

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. Perform and document laboratory investigations to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrence are considered and implemented. Execute associated CAPA.
• Ensure data integrity is maintained for all applications, programs, and executed work. Ability to document all work using Good Documentation Practices and ALCOA++ principles.
• Troubleshoot and analyze nonconforming data. Completion of thorough investigations to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrence are considered and implemented.
• Perform internal audits and GEMBA walk-throughs of laboratory areas to maintain compliance
• Communicate with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure that Company objectives are met on schedule
• Perform viable and non-viable environmental monitoring in support of Manufacturing and Quality Control in the form of air testing, surface testing, personnel testing and particulate monitoring, inside the aseptic clean rooms, as necessary
• Oversight of critical processing steps performed by Manufacturing during aseptic product manufacture, ensuring accuracy of steps performed
• Training of other employees as necessary

Qualifications

BASIC MINIMUM REQUIREMENTS:

• BS in a related scientific discipline
• At least 4 years of microbiology experience in a GMP biologics or pharmaceutical environment
• Experience with BacT rapid sterility assay, endotoxin testing, growth promotion, aseptic process media fills, and environmental monitoring required. Experience with cell therapy preferred.
• Knowledge of Current Good Manufacturing Practice, Good Documentation Practices, and Industry standards required
• Experience in aseptic processing and mammalian cell culture production
• Familiarity of 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

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 a Disabled and Veteran Equal Employment Opportunity employer.