Job Description :
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.
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