Job Summary

Quality Control Microbiology – Perform microbiology LAL (Endotoxin), bioburden assay and validation activities supporting GMP, Clinical, development product release. This position is to support related QC Assay testing/validation.

Job Description

• Capable of conducting microbiological method validation including bioburden and (endotoxin) methods supporting biopharmaceutical, clinical and development products.
• Conduct execution of microbiological methods per approved protocols and testing of routine and investigational samples.
• Familiarities with all microbiological compendial methods for specific commercial products. Maintains records of method qualification/validation and other microbiological related methods.
• Keeps current with revisions to compendial monographs and to compendial test methods used in the microbiology division.

Skills Required

• Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments.
• Thorough knowledge of microbiological analytical methods, compendial requirements (USP, EP, JP). Knowledge of biologics and manufacturing processes.
• Strong computer skills (Word, Excel, Access, PowerPoint, LIMS, SAP).
• Prior experience in a QC microbiology testing laboratory.
• Ability to work independently with minimum supervision.

Education/Training/Certifications

• Bachelor of Science in Microbiology or related science degree or technical field.
• Minimum experience of 2+ years of in microbiological method validation in pharmaceutical or related industry or an equivalent combination of education and experience.

Additional Requirements

• Worker Shift Start Time: 07:00 AM

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