West Point, PA, 19486, USA
3 days ago
Quality Deviation Specialist
Job Title: Quality Deviation Specialist Location: West Point, PA Hours/Schedule: Mon- Fri 8am- 5pm Type: Contract Responsibilities + Leads and/or works as a team member on manufacturing investigations and/or process improvement projects. + Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to identify root cause and propose effective corrective and preventative actions (CAPAs). + Assures consistent application of standardized work, engineering, and process tools. + Provides technical support to manufacturing shop floor for problems and issues. + Conducts and designs experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale. + Writes technical documents to support closure of deviations using the SAP system. + Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation. Requirements + B.S. degree in Engineering or Sciences. + Minimum one (1) year post-bachelor’s degree experience in a GMP (good manufacturing practices) manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree with <1 year experience). + Demonstrated ability to drive results to hit assigned due dates. + Strong communication, collaboration skills and ability to drive accountability. + Strong problem-solving skillset + Vaccine manufacturing + Sterile processing + Experience authoring Benefits System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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