Description: · The candidate will perform Serology Testing for in-process product to ensure product is meeting specifications. Read and understand technical documentation associated with specific disciplines. · Identify areas for process improvement including safety, environmental, quality, compliance, yield, productivity and cost. · Work with Manufacturing Operations, Process Engineering, Process Development, Maintenance Operations, Automation, Engineering Systems, Quality Control, Quality Assurance, and Validation departments to implement process improvements. · Assist with change control, equipment startup and technical training. · Assure regulatory compliance and technical feasibility. · Provide technical support to investigation and resolution of process deviations. · With guidance from Senior Serologists, perform equipment, process, and cleaning validation duties. · Maintain, complete and review batch records. Develop or revise protocols, coordinate resources and schedule qualification runs. Summarize results and conclusions in reports. · With guidance from Senior Serologists, conduct investigations and studies to troubleshoot manufacturing problems. · Document results in technical memos. · Collect, track, and trend environmental hazard training must be completed. · This is not an exhaustive, comprehensive listing of job functions. · May perform other duties as assigned. · A minimum of an Associate degree in a scientific discipline or related field is preferred and or one year work experience in a related field. · A degree in Medical Technology is preferred. · Training in a commercial production facility, Hospital or Blood Bank environment is required. · Knowledge of cGMP's or FDA regulations is an asset. · Experience with automated systems such as AutoVue, ProVue or MTS is also preferred. · This is a third shift position and will require the flexibility to work other shifts and weekends, as needed by business. · This position will require the ability to lift up to 50lbs. This position will be based in Raritan, NJ Please Note: Submit your resume through this posting. Please Do Not Call, we will call you. ======================================================== Pioneer Data Systems, Inc. an "Inc 500" and "NJ Technology Fast 50" company, is a preferred provider to Fortune 500 Clients nationwide. We distinguish ourselves by providing outstanding service to our clients using emerging and innovative technologies. PDS offers excellent compensation, benefits and constant flow of new challenges to its consultants. We understand that every professional has different needs, so we will work with you to determine a suitable benefit package, which includes; group medical plan (Section 125), 401K Plan, etc. We are an E-Verify Employer. For further information, please visit us at www.pioneerdata.com
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