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Source One Technical Solutions · 1 day ago

QC Microbiologist I

Fort Worth, TX

Contract

Onsite

Entry Level

$23.19/hr - $23.19/hr

1+ years exp

Source One Technical Solutions is seeking a Microbiologist for a QC role with a global medical device company. The role involves ensuring lab cleanliness, developing testing methods, training analysts, and participating in audits and compliance activities.

ConsultingPharmaceuticalRetailStaffing Agency

No H1B

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

Microbiological testingBioburden testingLAL testingStability testingPET testingMethod validationTechnical report writingTraining othersTroubleshooting equipmentStatistical analysisCompliance monitoringBiological assay developmentDocumentation