Quality Control Analyst I

About the job

**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.