QC Associate - Biotech
Lab Support - Silicon Valley, CA

This job posting is no longer available on On Assignment. Find similar jobs: Qualitycontrol Associate jobs - Lab Support jobs

Perform microbiological and biochemical and lot testing of raw materials, E. coli and mammalian cell banks, commercial and clinical fermentation, purification, and final product samples to meet standard lead times * Review data and assess against established acceptance criteria * Identify discrepancies, participate in quality investigations and CAPA initiatives as needed * Participate in assay, facility, equipment and process validation * Order lab supplies and maintain inventory * Perform equipment qualification and maintenance activities * Prepare and maintain standards, controls, stocks, and cultures per established protocols * Support the maintenance and compliance of operational areas * Assure strict adherence to cGMPs throughout operation * Perform SWAT and routine maintenance duties to ensure inspection ready state * Ensure training qualifications are up to date * Identify and support resolution of technical problems * Actively participate in group and project teamwork; project and process improvements * Perform SWAT and routine maintenance duties to ensure inspection ready state * Draft protocols and reports under supervision

Experience in the conduction of microbiological assays such as bioburden, PCR, LAL and Sterility testing is a plus * Ability to communicate clearly and professionally in writing and verbally * Basic knowledge of scientific theories, principles and techniques used in biological or analytical test procedures * Ability to exercise sound judgment, reasoning and problem solving * Sound knowledge of cGMPs or equivalent regulations * Ability to work off-shift, weekends and holidays as needed * Experience using basic computer software (Word, Excel, and PowerPoint). Working knowledge of SAP, Labware LIMS and Livelink a plus * Must be physically able to perform the following tasks: - Work in a laboratory environment including biosafety cabinets and isolator half-suits - Lift up to 25lbs - Sit, stand and move within work space

BA/BS degree preferably in Life Science and a minimum of 0-2 years relevant experience in the bio/pharmaceutical industry or an equivalent combination of education and experience

To apply email your resume to lisa.kwan@labsupport.com and write, "QA Associate" in the subject line.

On Assignment - 2 years ago - save job - copy to clipboard
About this company
32 reviews