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Location

Birmingham, AL | United States

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Job description

Full job description

This position is responsible for conducting routine microbiological testing, documentation, and data analysis, of release and in-process pharmaceutical material, utilities, 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:

o 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.

o 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.

o 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 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 MSDS to establish chemical hazards, observes the appropriate laboratory procedures and reports all incidents that could threaten the safety of laboratory personnel
• 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 Evonik procedures and test methods.

Skills:

• Microbiology
• GMP
• Environmental monitoring
• Assay
• Quality control

Additional Skills & 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.

Experience Level:

Intermediate Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.

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