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 firstname.lastname@example.org and write, "QA Associate" in the subject line.
On Assignment - 23 months ago