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Microbiologist

Company: Aerotek
Location: Saint Louis
Posted on: April 10, 2021

Job Description:

Description:SUMMARY:Provides technical support to Microbiological Services by displaying technical experience in a variety of Aseptic Processing Principles (clean room environment), Aseptic Sampling, Disinfection, Sterilization, and Microbiology topics. This role serves as a contributor to process deviation reporting, investigations and determination of root causes. Leads efforts to improve process performance, procedures and reporting to meet changing quality and regulatory compliance. Provides direction for microbiological requirements, aseptic processing principles, microbiological support for validation of new equipment and production areas, methods and sterilization processes and supports development for manufacturing operations. Display technical experience in microbiology and aseptic techniques, principles, theories, concepts, and industry practices/standards. Evaluates changes in approved aseptic manufacturing facilities and equipment for conformance to microbiological quality standards. Writes evaluations to support Change Control Requests, ROIs, URS, etc. Contribution to SOP's, qualification protocols, technical reports, project plans, etc. Focuses on leading/participating in defined operations work assigned. Hands-on laboratory work in the Microbiology laboratory or the Aseptic Processing Area may be required.Works under general supervision, referring to policies and practices for guidance and follows established procedures. Contributes to the completion of specific team objectives and assigned project milestones. The successful candidate will help drive continuous improvement and help to maintain a state of regulatory audit readiness over QC-Micro programs. Demonstrates knowledge and self-direction to make sound decisions aligned with operational processes and quality requirements. ROLE RESPONSIBILITIES: Responsible for execution of a portion of the microbiological and environmental monitoring programs by: Support on investigation writing, review and approval for environmental monitoring events in relation to the Aseptic Processing Area.Interprets and evaluates data in terms of accuracy, precision, trends and potential GMP impact and recommends appropriate corrective actions. Performs trend analysis of viable and non-viable environmental monitoring data in support of aseptic operations. Provides subject matter expertise and oversight of the daily activities of technical level colleagues, may train others in these practices and techniques.Independently writes SOP's, technical reports, project plans, microbiological assessments, etc. Conducts risk management assessments of the classified production areas to revise or establish the routine environmental monitoring program for those areas with understanding of EU and US regulatory requirements. Supports validation and qualification activities for aseptic processes and equipmentApplies existing techniques and procedures, with recommendations, and implements modifications for improved efficiency.Skills:aseptic processing, microbiology, environmental monitoring, clean roomTop Skills Details:Bachelor's degree in Microbiology or related field3+ years of experience supporting aseptic processes or micro-testing practices Associate degree levels in biology or related field with 5+ years' experience in similar role performing QC micro-related activities will be considered. Strong computer technical skills (MS Office, Excel, Business Object/Crystal, Trackwise) with sound knowledge of data entry and QC-Micro reporting concepts and practicesPREFERRED QUALIFICATIONS:Candidates will possess experience with microbiological disciplines: Aseptic Processing, Environmental Monitoring of a Pharmaceutical Cleanroom Environment (viable and non-viable), and Aseptic GowningAdditional Skills & Qualifications:Bachelor's degree in Microbiology or related field3+ years of experience supporting aseptic processes or micro-testing practices Associate degree levels in biology or related field with 5+ years' experience in similar role performing QC micro-related activities will be considered. Strong computer technical skills (MS Office, Excel, Business Object/Crystal, Trackwise) with sound knowledge of data entry and QC-Micro reporting concepts and practicesPREFERRED QUALIFICATIONS:Candidates will possess experience with microbiological disciplines: Aseptic Processing, Environmental Monitoring of a Pharmaceutical Cleanroom Environment (viable and non-viable), and Aseptic GowningExperience Level:Expert Level About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, St. Louis , Microbiologist, Other , Saint Louis, Missouri

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