Microbiologist I

Company Overview

TriRx Pharmaceutical Services is evolving the perception of what a contract development and manufacturing partner should be.

TriRx was built and is operated by one of the pharmaceutical industry’s most reputable, experienced leadership teams. Having served as both contract service providers and customers, we have a deep and multifaceted understanding of pharmaceutical processes, and the challenges companies face in bringing products to market. Our collective experience is what enables us – and drives us – to exceed expectations where other CDMOs fall short.

TriRx Shawnee is seeking people who share in our commitment to excellence to join our growing team.

Position Summary

Incumbents in this position are responsible for testing of raw materials, intermediates and finished products according to cGMP's in order to ensure satisfactory levels of microbial quality are met. Fundamental microbiological principles are applied in order to interpret test results. Responsibilities also include monitoring of controlled environments to ensure that manufacturing and testing processes occur under appropriate conditions. The incumbent maintains, compiles and reviews laboratory worksheets to assure accuracy of test data.

On a daily basis, the incumbent must plan for and respond to the analytical needs of a laboratory involved in fast turnaround of pharmaceutical analyses to meet manufacturing deadlines. This planning requires good communication, attention to detail, organization skills and the use of the various analytical instrumentation systems and procedures. All incumbents are responsible for following applicable Division & Company policies and procedures.

Responsibilities

• Performs testing of raw material, in-process and finished product samples according to approved procedures.
• Perform Environmental monitoring of the manufacturing and laboratory facilities including cleanroom environments, personnel, water systems, compressed gases, and laminar flow hoods.
• Identify microbial isolates using manual or automated techniques per written procedures in a timeframe that supports customer requirements.
• Prepares media, solutions, materials and equipment to support sampling and testing.
• Performs growth promotion and quality testing on media used for microbiological testing, environmental monitoring and sterility testing in the Microbiology QC Department as needed.
• Maintain the record storage systems in a manner that ensures quick and reliable retrieval of the data as needed.
• Provide support to laboratory projects and assist other team members as needed.
• Adhere to the pertinent aspects of compliance and plant safety programs.
• Critical understanding of proper and thorough laboratory investigations
• Support QA Operations as required for laboratory investigations
• Continuous improvement and assessment of laboratory practices to eliminate over-processing of data
• Adhere to GMP and/or GLP standards as required for daily operations
  
  

Basic Qualifications

• BA or BS, in a related, such as biology, chemistry, microbiology, or biochemistry.
• 1+ year laboratory experience, which can include academic experience or microbiology laboratory.
• The incumbent should have basic background for the understanding, planning, and execution of laboratory Standard Operating Procedures relating to instrument use, sample analysis, document generation and control, personal safety, and environmental safety.
• Knowledge of FDA regulations (or similar regulated environment) to include Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP)
• Basic computer skills are required.
• The incumbent must be able to pass a DEA background check.
• Proven, effective written and verbal communication skills.
• Demonstrated skills in the use of a wide range of microbiology test methods and instrumentation, including the following:
• Bioburden testing
• Endotoxin testing
• Aseptic technique
• Water quality sampling and testing
  
  

EEO Statement: TriRx Pharmaceutical Services is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.