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, and they must be able to be the point of contact for all questions related to quality control activities related to microbiology in the lab. Training of other employees, updating processes, performing required testing, and investigating non-conformances are all activities that may be required.

The qualified individual MUST be an expert in:

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

• 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 recurrent are considered 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

BASIC 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. 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
• Must be able to work independently and train others as needed

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.