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Quality Control Associate Environmental Monitoring HIT - Military Veterans

Location
Hillsboro, OR, United States

Posted on
May 23, 2020

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nJob Description SummarynThis position is part of Genentech’s’ Pharma Technical – Hillsboro Individualized Therapies (HIT) team working on the individualized NeoAntigen Specific Therapy (iNeST) platform based in Hillsboro, Oregon. iNeST is a next generation immunotherapy for the treatment of patients with cancer manufactured on a per patient basis. As a member of the HIT QC team, you will be supporting the start-up of a QC laboratory capable of high throughput analysis. You will help define the requirements for QC operations and will establish processes that will enable the QC organization to operate successfully. This role provides the opportunity to closely partner with the Genentech iNeST, development and Global QC teams as you work on start-up activities like establishing the laboratory information management system, qualifying equipment, writing procedures and developing/validating test methods. Responsibilities include performing and reviewing a variety of assays in the Quality Control organization focused on the analysis of an investigational clinical product. Specifically, the ideal candidate will have experience establishing an environmental monitoring program and executing the test methods (bioburden, particle counting, etc.) that used in support of environmental monitoring. Additional responsibilities include LIMS master data management, data system administration and stability program management.nnResponsibilities:nnInterpret data, troubleshoot assay failures and equipment issues while adhering to guidelines on cGMP documentation.nSupport method cycle development, performance qualifications/validations, method transfers, discrepancy/out-of-specification investigations and collaborate with external groups to identify improvement opportunities in technology and business processes.nIndependently manage competing priorities with limited instruction.nApply basic theory and technical principles to address moderately complex problems.nTroubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.nServe as a technical subject matter expert (SME) in support of department functions.nCollaborate with external groups to identify technology and business processes that will support high throughput analyticsnDefine the user requirements for laboratory equipment and support purchasingnSupport the implementation of the Laboratory Information Management SystemnSupport the startup and maintenance of the stability programnReceive and provide trainingnPerform any other tasks as requested by Management to support Quality oversight activitiesnnnQualifications: Education, Experience, Knowledge and Skills:nnB.A. or B.S. degree (preferably in Biochemistry, Chemistry or relevant scientific discipline) and at least 2 years of experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experience.nPrevious experience with individualized therapies is a plusnLaboratory start-up experience is a plusnHands-on laboratory experience with microbiological and bioassay techniquesnSound knowledge of cGMPs or equivalent regulationsnRoutinely exercises sound judgment, reasoning and problem solvingnCapable of working under moderate supervision and determining own short-term prioritiesnWork in office and laboratory environmentnLift up to 25 lbs may be requirednAbility to sit, stand and move within work space for extended periodsnMay be required to sit at a computer terminal for extended periodsnMust be able to travel to other sites for training and method activities as requirednn#LI-AD1nRoche is an equal opportunity employer.Quality, Quality > Quality Controln

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