Quality Control Analyst - Fort Worth
Core
Conduct routine and non-routine biological and microbiological testing of in-process and raw materials, environmental samples, finished goods, and stability samples.
Role type
Quality Control Analyst I (Microbiology)
Builds
Test data and regulatory submissions
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
Microbiological testing (bioburden, microbial limits, endotoxin, sterility), USP/ISO guidelines knowledge, LIMS, statistical analysis, method validation, equipment calibration, SOP development
Preferred skills
PCR, ELISA, flow cytometry experience, troubleshooting, data trend analysis
Technologies
LIMS, PCR, ELISA, flow cytometry
Responsibilities
Conduct biological and microbiological testing of materials and samples; monitor testing against specifications and protocols; interpret results and assess data suitability for release; investigate and report out-of-specification findings and contamination; develop, qualify, validate, and transfer biological and microbiological methods; maintain laboratory cleanliness and biosafety; troubleshoot, calibrate, and maintain laboratory equipment; train colleagues in biological assays; coordinate testing with contract laboratories; prepare standard operating procedures, testing protocols, and technical reports; compile test data and perform statistical and trend analyses.
Seniority
Junior, hands-on IC