Quality Control Analyst
American IT SystemsUnited StatesMIDPosted 48m ago
microbiological testingbioburden testingmicrobial limit testingbacteria endotoxinmicrobial identificationsterility testingpreservative efficacy testingUSPISO guidelinesLIMS systemPCRELISAflow cytometry
About the Role
We are seeking a Quality Control Analyst to join our team in Fort Worth, TX. This role involves performing various microbiological and biological testing procedures to ensure product quality and compliance with regulatory standards.
Key Responsibilities
• Perform microbiological testing including bioburden testing, microbial limit testing, bacteria endotoxin, microbial identification via gram stain, sterility testing, and preservative efficacy testing
• Develop and qualify new microbiological or biological testing methods
• Train other analysts to perform biological assays and microbiological procedures
• Perform visual inspections of biological samples and finished products
• Participate in internal assessments and audits related to biological testing and biosafety compliance
• Identify and troubleshoot issues with biological testing equipment
• Evaluate new biological technologies and methods and recommend their implementation
• Serve as a technical liaison between microbiology/biology labs and other departments
• Write technical reports or documentation such as deviation reports, biological testing protocols, and microbial trend analyses
• Write or revise standard operating procedures for biological and microbiological quality control
• Supply biological quality control data necessary for regulatory submissions
• Receive and inspect biological raw materials
• Review data from contract microbiology labs to ensure accuracy and regulatory compliance
• Prepare or review method transfer documentation for biological assays