Quality Engineer - SterilizationPosted: November 17, 2009
Quality Engineer - Sterilization
Staffworks is seeking a scientist specializing in sterilization procedures for our client located in Central New York (Near Syracuse). Full time benefits provided plus relocation expenses covered.
Coordinate, schedule, implement, approve and monitor aspects of all environmental and sterility assurance activities in compliance with regulatory and company policies and procedures. Review and approve sterility validation protocols and reports. Prepare quarterly dose audit and bioburden samples, annual E&O samples and audit of post sterile paperwork when needed. Conduct audits of post sterile product paperwork. Prepare, obtain, and ship pre-sterile microbial content samples. Monitor test data from testing facilities. Interface with inside and outside contacts by providing technical support to other departments in regards to microbiology, biocompatibility and sterilization. Gather various test data, maintain data and trends, logs, lists, and records. Review data using statistical methods and take necessary actions as required. Monitor, set up and coordinate the program sampling by taking viable and non-viable samples at the applicable facilities in accordance with company policies and procedures. Train and mentor technicians at remote locations, and ensure employees are following company policies and procedures.
BS Degree in Life Sciences required, with a major in Microbiology preferred. Experience with medical device steam, ethylene oxide, radiation sterilization procedures, and routine finished product sterility release are highly desired. Must possess strong organizational, troubleshooting and investigatory skills for sterilization, bioburden, and environmental deviations and excursions. Knowledge of safe work practices in handling chemicals and biological materials, and medical device regulations and industrial sterilization and microbiological controls are also highly desired. Proficient in Microsoft Office applications. Ability to work independently and in a cross-functional team environment. Please refer to job code P97E3 when responding to this ad.
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