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.
Numbers & Facts
Location
Ft Worth, TX
Skills
Analysis Skillsunmatched
Assaysunmatched
Autoclaveunmatched
Biological Assayunmatched
Biologyunmatched
Contract Reviewunmatched
Corrective Actionunmatched
Data Collectionunmatched
Documentationunmatched
Equipment Maintenance/Repairunmatched
Identify Issuesunmatched
Internal Auditunmatched
Laboratory Equipmentunmatched
Maintain Complianceunmatched
Microbiologyunmatched
Polymerase Chain Reaction (PCR)unmatched
Problem Solving Skillsunmatched
Procedure Developmentunmatched
Process Analysisunmatched
Quality Assurance Methodologyunmatched
Quality Controlunmatched
Receiving Inspectionunmatched
Regulatory Submissionsunmatched
Reporting Skillsunmatched
Standard Operating Procedures (SOP)unmatched
Statisticsunmatched
Support Documentationunmatched
Technical Writingunmatched
Test Dataunmatched
Test Equipmentunmatched
Test Labunmatched
Testingunmatched
Trend Analysisunmatched
🎯
Be found by employers
5,500+ employers search our resume database daily. Add yours to get found by recruiters looking for candidates like you.
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.