SR. QUALITY CONTROL MICROBIOLOGIST
PRIMARY PURPOSE OF POSITION:
A Senior Quality Control Microbiologist will perform in a cGMP environment following FDA, ISO and ICH guidelines. Responsibilities will include performance of environmental monitoring tests in controlled areas and performance of chemical and microbiology testing of Purified and/or WFI water systems according to USP, EP, BP, JP, ISO or other guidance. It may also include Endotoxin (Gel-Clot & Kinetic Chromogenic methods), and endotoxin method validation, i.e. Inhibition/Enhancement, maintenance of microbiology test media, growth promotion testing, organism characterization and organism identification. Experience in developing and validating methods is required. Fluency in compendial testing such as Microbial Limits (preparatory & screening), Sterility and Sterility Test Method Validation (Bacteriostasis/Fungistasis), Bacterial Identification using Biolog Identification System, Preservative Effectiveness Testing, familiarity with validation of and writing protocols for instruments and equipment, excellent knowledge in GMP and ISO requirements, experience and understanding of regulations and test procedures for medical devices are desired. Additionally, the successful candidate will have knowledge and experience in regulations for drug development pertaining to microbiology. Must be detail oriented and possess the ability to work within a teamwork environment.
Quality Control/Microbiology background, (microbiology, chemistry background). Experience with environmental monitoring, gowning, water testing. Must have excellent oral and written communication skills. Proactive, creative, willing to learn quickly, well organized. Requires a B.S. Degree in Microbiology with 4 to 8+ years of experience in pharmaceutical microbiology.