Quality Control Analyst

Motion Recruitment; Fort Worth (TX); On-site; USD 70,000 - 100,000; Full time

Job summary

Motion Recruitment in Fort Worth, TX is seeking a laboratory professional to perform routine and non-routine biological and microbiological analyses, inspections, and data interpretation to support release decisions.

The role involves method development, validations, transfers, documentation, and collaboration with contract labs to ensure regulatory compliance and biosafety standards.

Responsibilities

• 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.
• Compile biological test data and perform appropriate statistical or trend analyses.
• 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.
• 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.
• 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.
• 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.

Job description

• 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.
• 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.