Quality Control Analyst III, Viral based Therapeutics 7/20/2018
Lonza Houston, Inc
JOB DESCRIPTIONAPPLY Responsible for development, performance, and validation of Quality Control assays in a GMP environment in support of the development, production, release, and distribution of biological products. May represent the Quality Control department on project teams. Assays performed may include HPLC, ELISA, cellular-based and microbiological assays, and other tests for the release of biologic products, as well as, environmental monitoring. All testing is performed in accordance with written standard operating procedures and cGMPs. Takes the lead on writing Test Records, Change Controls, Deviations and other Quality documentation required for cGMP sampling and testing. Performs release and stability testing, in-process testing, QC inspections, and audits, QC documentation, equipment maintenance and calibration and QC laboratory maintenance according to official standard operating procedures and cGMP regulations. Understand and performs laboratory assays according to official procedures on raw materials, in-process material, final product, and stability samples, and/or environmental monitoring. Records observations and results according to the QC documentation systems. Performs non-routine assays and executes specific projects on the request of the supervisor. Participates in writing of official procedures in the QC laboratory as needed. Assists in troubleshooting of assays, processes, procedures, and equipment. Maintains sample accountability for all samples actively being processed. Maintains adequate inventory of laboratory supplies. Participates in peer review of test results. Perform job functions in compliance with cGMPs and maintain accurate and legible laboratory records.
Write original and revise current SOPs, Forms and Test Records, Writes, edits, and approves deviations and CAPAs as required. Responsible for initiating change controls and completing necessary documentation. Bachelor's degree in Science, Biology, or related plus 3 years experience in job offered or related occupation. Must have experience in a biotech/pharmaceutical setting. Experience handing and testing virus-based products while wearing adequate personal protective measures. Must be able to write complex procedures and reports without supervision and use spreadsheets, databases, and word processing software. Duties entail working with Microsoft applications, especially Word and Excel. Able to identify and respond to complex problems, interpret complex data, draw valid conclusions, and perform aseptic processes.