Performs biological assays of clinical and/or commercial product raw materials, production in-process samples, finished product, environmental monitoring samples, process & cleaning validation samples and components as well as some specialized techniques. Assays are qualitative, quantitative, and investigational in nature and are performed in compliance with USP, FDA and other regulatory body requirements, Mallinckrodt standard operating procedures, and approved license requirements. Results are compared with specifications and documented. Incumbent has mastered most or all of fundamental technical and quality concepts.
Required Skills & Background
Education required/ preferred:
BS or BA in an appropriate scientific discipline (e.g. biology, microbiology, biology) with 1-3 years pharmaceutical microbiology experience.
Good interpersonal and verbal/written communication skills; able to use computer for data analysis. Ability to perform multiple tasks simultaneously with accuracy and precision. Ability to follow directions; read and understand SOPs.
Knowledge of laboratory safety, material safety; working knowledge of cGMPs, GLPs, and FDA requirements. Self-motivated, energetic, enthusiastic, and team oriented.
Ability to train analysts; kinetic LAL; gel-clot LAL; environmental monitoring; filtration; aseptic technique; particulate testing, investigation writing. Effective communication with both team members and other plant support groups.