Associate Scientist

Company: Sirius Technical Services
Location: Birmingham
Posted on: January 12, 2021

Job Description:

Sirius Technical Services is currently seeking candidates for an Associate Scientist position in Birmingham, AL. This is considered a long-term contract position. This position is responsible for conducting routine microbiological testing, documentation, and data analysis, of release and in-process pharmaceutical material, utilit ies, raw materials, facilities and equipment. Additionally, the Associate Scientist will be responsible for upkeep of the laboratory, laboratory supplies, and other various routine laboratory tasks. Has a sound understanding of the skills required to perform the following routine 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) Biological Indicators Performance Test, e) Identification of bacteria and fungi using microscopy and phenotypic/genotypic methods. -- Environmental Monitoring - Monitoring of Classified Areas using a) active/passive air sampling methods and RODAC/swab surface sampling methods for the detection of bacteria and fungi; and b) Air sampling methods for the detection of Total Particulates; trending of this data to detect anomalies and characterize the transient and resident microflora. -- Utilities -Testing of a) clean steam and Water for Injection for total microbial count and presence of endotoxins; and b) nitrogen and process air for total microbial count and total particulates. -- Data analysis and entry into software systems such as Microbiology Information Management Systems (MIMS). -- GMP Documentation - Document test results and conclusions in a GMP manner. Ensure test forms are complete before submission for approval. -- Performs responsibilities in compliance with company 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 MSDS to establish chemical hazards, observes the appropriate laboratory procedures and reports all incidents that could threaten the safety of laboratory personnel Strategic Focus: -- Perform responsibilities in compliance with company quality systems and provide support to all manufacturing and validation 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 USP, EU, ISO regulations and company procedures and test methods. Qualifications: -- Bachelor's degree in microbiology, biological sciences, or related field of study -- Minimum 2 yr. experience in a clinical, academic, or industrial/pharmaceutical microbiology laboratories. -- Experience in microbiological assays and testing. -- Desired experience in environmental monitoring and trending. -- Desired experience in the testing of utilities. -- Excellent written and verbal communication skills. -- Excellent organizational and leadership skills. -- Proficiency in Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMP). -- Excellent computer skills including experience with spreadsheets and databases. -- Ability to use a respirator. -- Ability to work with microorganisms and hot liquids. Sirius Technical Services Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to characteristics such as race, color, national origin, religion, gender, age, marital status, disability, veteran status, citizenship status, sexual orientation, gender identity, or any other status protected by law. Job Requirements:-- 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) Biological Indicators Performance Test, e) Identification of bacteria and fungi using microscopy and phenotypic/genotypic methods.-- Environmental Monitoring - Monitoring of Classified Areas using a) active/passive air sampling methods and RODAC/swab surface sampling methods for the detection of bacteria and fungi; and b) Air sampling methods for the detection of Total Particulates; trending of this data to detect anomalies and characterize the transient and resident microflora.-- Utilities -Testing of a) clean steam and Water for Injection for total microbial count and presence of endotoxins; and b) nitrogen and process air for total microbial count and total particulates.-- Data analysis and entry into software systems such as Microbiology Information Management Systems (MIMS).-- GMP Documentation - Document test results and conclusions in a GMP manner. Ensure test forms are complete before submission for approval.-- Performs responsibilities in compliance with company 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 MSDS to establish chemical hazards, observes the appropriate laboratory procedures and reports all incidents that could threaten the safety of laboratory personnel

Keywords: Sirius Technical Services, Birmingham , Associate Scientist, Other , Birmingham, Alabama