Quality Control Analyst I (Microbiology)

Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant to our direct client, a global medical device company in Fort Worth, TX.

Job Title: Quality Control Analyst I (Microbiology) - Contractor

Pay Rate: $23.19/hr (W-2)

Duration: 12 months with likely extension

40 hours/week, Mon-Fri

Candidates must have one or more of the following microbiology skills: Microbial identification, LAL, Sterility, bioburden and Preservative efficacy testing. They must be able to explain the testing process during the interview.

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.