Scalence L.L.C. · 1 day ago
Quality Control Analyst I
Fort Worth, TX
Full-time
Onsite
New Grad, Entry Level
$20/hr - $25.36/hrScalence L.L.C. is a company focused on quality control in biological testing. They are seeking a Quality Control Analyst I to ensure lab cleanliness, develop testing methods, and train analysts while maintaining compliance with biosafety standards.
Information Technology & Services
Responsibilities
Ensure that lab cleanliness and biosafety standards are maintained, including proper handling and disposal of biological materials
Develop and qualify new microbiological or biological testing methods (e.g., microbial limits, endotoxin testing, cell-based assays)
Train other analysts to perform biological assays and microbiological procedures
Perform visual inspections of biological samples and finished products for contamination or abnormalities
Participate in internal assessments and audits related to biological testing and biosafety compliance
Identify and troubleshoot issues with biological testing equipment (e.g., incubators, autoclaves, biosafety cabinets)
Evaluate new biological technologies and methods (e.g., PCR, ELISA, flow cytometry) and recommend their implementation
Serve as a technical liaison between microbiology/biology labs and other departments, vendors, or contractors
Coordinate biological and microbiological testing with contract laboratories and vendors
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 (e.g., cell lines, reagents, growth media)
Review data from contract microbiology labs to ensure accuracy and regulatory compliance
Prepare or review method transfer documentation for biological assays, including technical transfer protocols or reports
Perform validations or transfers of biological and microbiological methods in accordance with applicable guidelines
Participate in out-of-specification and contamination investigations and recommend corrective actions
Monitor biological testing procedures to ensure compliance with established specifications and protocols
Investigate or report questionable biological test results
Interpret biological test results, compare them to specifications, and make recommendations on data suitability for release
Identify biological quality problems and recommend solutions
Evaluate biological testing methods and procedures for potential improvements
Complete documentation needed to support biological testing procedures, including data capture forms and equipment logbooks
Calibrate, validate, or maintain biological lab equipment
Compile biological test data and perform appropriate statistical or trend analyses
Conduct routine and non-routine biological and microbiological analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples
Qualification
Required
Ensure that lab cleanliness and biosafety standards are maintained, including proper handling and disposal of biological materials
Develop and qualify new microbiological or biological testing methods (e.g., microbial limits, endotoxin testing, cell-based assays)
Train other analysts to perform biological assays and microbiological procedures
Perform visual inspections of biological samples and finished products for contamination or abnormalities
Participate in internal assessments and audits related to biological testing and biosafety compliance
Identify and troubleshoot issues with biological testing equipment (e.g., incubators, autoclaves, biosafety cabinets)
Evaluate new biological technologies and methods (e.g., PCR, ELISA, flow cytometry) and recommend their implementation
Serve as a technical liaison between microbiology/biology labs and other departments, vendors, or contractors
Coordinate biological and microbiological testing with contract laboratories and vendors
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 (e.g., cell lines, reagents, growth media)
Review data from contract microbiology labs to ensure accuracy and regulatory compliance
Prepare or review method transfer documentation for biological assays, including technical transfer protocols or reports
Perform validations or transfers of biological and microbiological methods in accordance with applicable guidelines
Participate in out-of-specification and contamination investigations and recommend corrective actions
Monitor biological testing procedures to ensure compliance with established specifications and protocols
Investigate or report questionable biological test results
Interpret biological test results, compare them to specifications, and make recommendations on data suitability for release
Identify biological quality problems and recommend solutions
Evaluate biological testing methods and procedures for potential improvements
Complete documentation needed to support biological testing procedures, including data capture forms and equipment logbooks
Calibrate, validate, or maintain biological lab equipment
Compile biological test data and perform appropriate statistical or trend analyses
Conduct routine and non-routine biological and microbiological analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples
Company
Scalence L.L.C.
In today’s dynamic and competitive market, success hinges on mastering three key areas: Data Intelligence, Business Resilience, and Digital Experience.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase