Microbiologist Sr. - (14000095)

Details  About Us At St. Jude Medical every one of us plays a role in our collective ability to save and improve lives. As an organization, we want to continue to grow and lead our industry in changing the way the world views the treatment of expensive, epidemic diseases. By seeing things from a different perspective, using our imagination, leading with character, and working with passion, we all have a role to play in making what we do possible. Are you ready to join us? We are an Equal Opportunity/Affirmative Action Employer.  Description   Position Summary: This position is for the microbiologist that consistently applies microbiological concepts to the manufacturing process of a medical device and understands and develops process monitoring/metrics to maintain microbiological quality of the final device.   Essential Functions: Provides Facility Microbiological Support o Record review of routine microbiological test results o Routine release of manufactured product o Technical support for facility issues in the areas of sterilization, environmental monitoring, and microbiological methods. o Handles routine out of specification test results, or more complex out of specification issues. o Data analysis of sterilization processes. o Participate in audits of sterilization, test lab, and biological product vendors. Documentation o Ensures correct documentation linkage flow for microbiologically related documents. o Writes new or updates current microbiologically related documents. Maintains understanding of applicable standards and applies them to qualifications and test methods. Writes protocols and reports for qualifications for sterilization and microbiological test methods. o Writes appropriate validation protocols; performs or oversees validations for new technologies, equipment, and/or test methods; creates documentation for implementation. o Develops sterilization cycles and laboratory test methods. o Works with technicians in conducting these qualifications. Technical Training o Provides training to laboratory technicians on new equipment or new test procedures. o Provides training in the areas of sterilization validation and sterilization processes. Authority to sign off Qualifications, DDAs, NCMRs, COs, FMEAs, PDP forms. Member of R&D product teams, Operations project teams, or supports other projects as Directed by Department Manager.  Qualifications: Four year degree in microbiology or related science, or a four year degree and work in the field of microbiology. With BS Degree: Minimum of 7 years in a medical device/pharmaceutical, or related industry.  Cumulation of 7 years of work experience in microbiology and sterilization. With Masters Degree: Minimum of 3 years in a medical device/pharmaceutical, or related industry, and cumulation of 4 years in microbiology and sterilization with a Masters degree in a scientific field. Person in this position demonstrates professional skills Articulates technical concepts well Excellent written communication. Person in this position has demonstrated troubleshooting skills in complex situations outside of routine out of specification issues, such as sterilization or contamination issues while at the Microbiologist II level   Primary Location : USA-Minnesota-Minnetonka Other Locations : USA-Minnesota-Plymouth Job : QL-Quality Assurance Schedule : Full-time Shift : Day Job Travel : Yes, 5 % of the Time Job Posting : Jan 29, 2014

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