Quality Control Analyst I

Motion Recruitment

  • Ft Worth, TX
  • 4 days ago

    Highlights

    Methods, Validation, and Improvements Develop and qualify new microbiological or biological testing methods (e.g., microbial limits, endotoxin testing, cell-based assays). RESPONSIBILITIES: Laboratory Testing and Analysis Conduct routine and non-routine biological and microbiological analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.

    Numbers & Facts

    LocationFt Worth, TX

    Description

    Job Title: Quality Control Analyst I
    Location: Ft Worth TX 76134
    Duration: 12 Months with possible ext.

    RESPONSIBILITIES:
    Laboratory Testing and Analysis
    • Conduct routine and non-routine biological and microbiological analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.
    • Perform visual inspections of biological samples and finished products for contamination or abnormalities.
    • Receive and inspect biological raw materials (e.g., cell lines, reagents, growth media).
    • Interpret biological test results, compare them to specifications, and make recommendations on data suitability for release.
    • Investigate or report questionable biological test results.
    • Compile biological test data and perform appropriate statistical or trend analyses.
    Methods, Validation, and Improvements
    • Develop and qualify new microbiological or biological testing methods (e.g., microbial limits, endotoxin testing, cell-based assays).
    • Perform validations or transfers of biological and microbiological methods in accordance with applicable guidelines.
    • Prepare or review method transfer documentation for biological assays, including technical transfer protocols or reports.
    • Evaluate biological testing methods and procedures for potential improvements.
    • Evaluate new biological technologies and methods (e.g., PCR, ELISA, flow cytometry) and recommend their implementation.
    • Monitor biological testing procedures to ensure compliance with established specifications and protocols.
    Quality Investigations and Compliance
    • Participate in out-of-specification and contamination investigations and recommend corrective actions.
    • Identify biological quality problems and recommend solutions.
    • Participate in internal assessments and audits related to biological testing and biosafety compliance.
    • Supply biological quality control data necessary for regulatory submissions.
    • Review data from contract microbiology labs to ensure accuracy and regulatory compliance.
    Documentation and Coordination
    • 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.
    • Complete documentation needed to support biological testing procedures, including data capture forms and equipment logbooks.
    • Coordinate biological and microbiological testing with contract laboratories and vendors.
    • Serve as a technical liaison between microbiology/biology labs and other departments, vendors, or contractors.
    Equipment, Training, and Biosafety
    • Identify and troubleshoot issues with biological testing equipment (e.g., incubators, autoclaves, biosafety cabinets).
    • Calibrate, validate, or maintain biological lab equipment.
    • Train other analysts to perform biological assays and microbiological procedures.
    • Ensure that lab cleanliness and biosafety standards are maintained, including proper handling and disposal of biological materials.

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