Job Title: Biochemistry Scientist/Engineer Location: Summit, NJ Hours/Schedule: 9am to 5pm Monday to Friday Type: Contract Overview Global pharma company looking to hire experienced Biochemistry Scientist/Engineer. Must bring a BS Degree in Biochemistry and experience with quality investigations, root cause analysis, CAPAs, and change controls. Responsibilities + Conduct thorough investigations (OOS, OOT, Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools. + Lead investigations and cross functional investigation teams, and close reports in a timely manner + Perform GEMBA walks with stakeholders to better understand process steps and evaluate Root Cause Analysis. + Work with functional teams to propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness. + Assess potential impact and risk to product or process associated changes may have upon change implementation and develop an appropriate mitigation strategy. + May Initiate change control documentation + Identify functional area SMEs to perform impact assessments as part of the change management process. + Ensure all investigations are completed in a timely manner. Notify stakeholders of any delays in a timely manner. + Provide technical support for manufacturing investigations / CAPAs / change controls as needed. + Support deviation investigation defense during audits and site inspections for QC compliance related inquiries. + Handle complex issues and solve problems with minimal guidance. + Provide training to new investigations team members + Serve as author or technical reviewer of departmental procedures as appropriate. + Support manufacturing and Quality Control testing of CAR T products as needed. + Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems. + Continuously support S12, living the “patients first” mission and fostering a “Right First Time” mindset. Requirements + Requires a Bachelor’s Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred). + Minimum 3 years of relevant work experience, preferably in a health authority regulated environment. + Previous experience working in a biopharmaceutical manufacturing facility is preferred (CAR T a plus). + Working experience of deviation investigations utilizing root cause analysis tools. + Working experience in the CAPA process and ability to identify and verify effectiveness. + Technical writing skills and ability to collaborate effectively in cross functional teams. + Proven ability to accurately and completely understand, follow, interpret, apply Global Regulatory and cGMP requirements. + Ability to support health authority inspections. + Knowledge of data trending and tracking, including use of statistical analysis software a plus. + Ability to utilize electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory Management system). + Hands on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality Control. + Ability to train new team members on the investigation process 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.