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Job Details

Microbiologist III

Company name
Stefanini

Location
Irvine, CA

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Microbiologist III

Stefanini

Irvine

CA

Job #634780739

Microbiologist III Hughes Street Irvine California 92618 Shift: Sunday-Thursday Position Summary This position is an experienced Microbiologist with a high level of expertise in most areas of the departmental functions. Develops methods and resolves technical issues. Trains and reviews the work of less senior level Microbiologists / Technicians. Capable of providing guidance to junior colleagues in the absence of supervisory staff. Essential Duties & Responsibilities Performs Microbiological testing on Raw Material, Finished Products and Stability samples - such as Sterility Testing, Bacterial Endotoxin testing, Particulate Matter testing, Bioburden test, Antibiotic assays, Microbial Limits test, Preservative Effectiveness test, Container Closure Integrity test and Bacterial Retention tests. Develops and validates new test methods. Works on special projects and studies such as validation. Writes protocol, review data and write final reports. Schedule, plan, perform and ensure that the assigned tasks and projects are completed in a timely manner. Prepares reports for other Microbiological tests. Trains and reviews work of less senior level Microbiologists / Technicians. Provide assistance to management in investigations for OOS conditions. Other duties, as assigned, or as business needs require. Primary Outcomes Provide subject matter expertise. Perform technically challenging tests. Provide guidance and some level of leadership. Position Requirements Education Required: B.S. in Microbiology or related sciences with 2 years of Microbiology coursework. Education Preferred M.S. in Microbiology or related sciences with 3-4 years of Microbiology coursework. Experience Required: A minimum of 5 years of experience in a Microbiology Lab with at least 4 years in a pharmaceutical/aseptic filling environment. Experience Preferred: A minimum of 3 years of experience in a Microbiology lab with at least 2 years in a pharmaceutical/ aseptic filling industry. Specialized or Technical Knowledge, Licenses, Certifications needed: Thorough knowledge of all areas of testing in a pharmaceutical Microbiology laboratory. Good knowledge of cGMPs, GLP, FDA guidelines, USP and EP. Excellent written and verbal communication skills and good Computer skills. Competencies: Please list five or six areas of competencies below that are necessary for the incumbent to do this position and that distinguish it from others similar to it. Technical Good knowledge of Microbiology subject matter, cGMPs, GLP, FDA guidelines, USP and EP. Planning and Organization Capable of working independently with minimum input from management, handling technically difficult projects. Good in planning, scheduling, executing and completing projects to meet deadlines. Interpersonal Excellent written and verbal communication skills. Team player. Problem Solving Possessing adequate knowledge of the departmental activities and technical knowledge to be able to solve problems and resolve issues arising out of difficulty of method. Provide assistance to management in investigations for OOS conditions. Communication Excellent written and verbal communication skills. Autonomy and Independence Ability to work with minimum instructions and supervision. Self-motivated and can complete projects with minimum input from supervisor.

Updated 04/15/2018

Company info

Stefanini
Website : http://stefanini.com

Company Profile
Stefanini has a team dedicated to understanding the technological requirements of the public sector demands to design customized solutions. We have solutions that meet all areas of the public sector, such as farming, education, utilities, transportation, judicial, health, safety, etc.

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