Quality Control Analyst I
$25 - $27 per hourASK Consulting LLC
Description Job title: Quality Control Analyst I Location: Fort Worth, TX 76134 (Onsite) Duration: 12 months' Pay rate - $25/hr. to $27/hr. Interviews: 2 Job Description:
- Experience in microbiological testing including bioburden testing, microbial limit testing, bacteria endotoxin, microbial identification via gram stain, sterility testing, and preservative efficacy testing.
- Doesn't need to have all the microbiological testing experience indicated above but should have some. Additionally, knowledge of USP, ISO guidelines, LIMS system is recommended.
- Good technical, communication and people's skills are key competency.
- 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.
Vacancy posted 7 hours ago
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