Job Description

• Aseptically perform sterility testing on finished products, in-process samples, and raw materials while adhering to sampling protocols and associated documents
• Maintain a clean laboratory by following routine proper disinfection practices when using the isolators or biosafety cabinets.
• Ensure compliance with GMP policies and SOPs in a production environment
• Review manufacturing schedule and applicable sampling plans for sampling points to ensure all samples are collected and tested in the appropriate time
• Review and reconcile all sterility test samples at the end of the incubation period to ensure all samples were appropriately taken, processed, and were within required limits
• Maintain and ensure sample chain of custody and perform all aspects of sample management including aliquoting, storage, receipt, and shipping
• Subculturing positive sterility tests and sending out plates for microbial identification
• Participate in lean lab operation, 6S laboratory layout, preventive action, and continuous improvement programs to reduce operating costs
• Calculate, evaluate, review, and properly communicate data verbally and in written format

Qualifications

_ Basic Minimum Qualifications:_

• Bachelor's or Master's degree in microbiology, life sciences, or other related degree concentration; other qualifications with additional experience will also be considered
• Minimum of 3 years related laboratory experience including sterility and bioburden
• Experience with microbiology, aseptic technique, and working in a GMP biologics production environment

** Preferred Experience:**

• Familiarity with USP <71> and rapid sterility test methods is preferred
• Experience with soft wall scans/isolation
• Strong computer, scientific, and organizational skills
• Excellent communication (oral and written) and attention to detail
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

Additional Information

Position is Full Time and Permanent: Monday-Friday 8:00am – 5:00pm. Candidates currently living within a commutable distance of Durham, NC are encouraged to apply. 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

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.