Associate Scientist

Associate Scientist

PRINCIPAL ACCOUNTABILITIES:

(The major activities or end results necessary to fulfill the position requirements on an ongoing basis)Has a sound understanding of the skills required to perform the following routine testing activities: Microbiological Assays and Testing - a) Turbidimetric/Chromogenic/Gel Clot method for the detection of bacterial endotoxins; b) Microbial Limits Test/Bioburden determination, manipulation, and maintenance of ATCC microorganisms and microbial isolates; c) Sterility Test, Growth Promotion and Particulate Matter determination using instrumentation and/or microscopy; d) Identification of bacteria and fungi using microscopy and phenotypic/genotypic methods; e) perform sample shipments to contract testing laboratories

• Validation Support- Ability to perform bioburden swab testing by current detection methods
• Ability to perform biological indicator testing by current methods
• Ability to perform endotoxin challenge vial testing
• GMP Documentation
• Document test results and conclusions in a GMP manner; Ensure test forms are complete before submission for approval
• Data entry for finished products and raw material in Laboratory Information Management System
• Performs responsibilities in compliance with Evonik quality systems and regulatory requirements
• Adheres to all company safety, health and environmental policies, procedures, and directives
• Conducts all laboratory activities in a safe manner by use of SDS and Safety Notifications to establish chemical hazards, observes the appropriate laboratory procedures and reports all incidents that could threaten the safety of laboratory personnel. Ensures all equipment is in a GMP/validated/calibrated state before use
• Technical Writing - Develop and execute protocols and Standard Operating Procedures for the implementation of microbiology equipment, assays and test methods. Reviews data generated by laboratory personnel
• Provides guidance and training to other laboratory personnel on operation of instruments and performing test methods
• Ability to troubleshoot instruments in the event of any problems
• Utilizes classical microbiological methods for the identification of microorganisms per current version of Bergey's Manual of Systematic Bacteriology
• Support of Environmental Monitoring Program: Utilities -Testing of a) clean steam, USP water, and Water for Injection for bioburden, total organic carbon (TOC), and presence of endotoxins; and b) nitrogen and process air for total microbial count and total particulates
• Environmental Monitoring of facilities for non-viable particulates, viable air and surface by use of calibrated and validated monitoring equipment and procedures
  
  

Other Responsibilities:

• Performs responsibilities in compliance with Evonik quality systems
• Adheres to all company safety, health and environmental policies, procedures and directives
• Conducts all laboratory activities in a safe manner by use of SDS to establish chemical hazards, observes the appropriate laboratory procedures and reports all incidents that could threaten the safety of laboratory personnel
• Data analysis and entry into software systems such as Microbiology Information Management Systems (MIMS)STRATEGIC FOCUS: (The focus desired and expected on the position over the next 1-3 years)
• Perform responsibilities in compliance with Evonik quality systems and provide support to all manufacturing activities
• Adhere to all company environmental, health and safety policies and procedures
• Conduct all laboratory and cleanroom activities in a safe manner and according to appropriate written procedures
• Perform microbiological assays according to US, EU, ISO regulations and Evonik procedures and test methods
• Maintain the laboratory metrics program
• Complete the qualification of sanitizers used in the manufacturing facilities

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With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.

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