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Engineer
4 days ago
79832
TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.
Our client, a leading pharmaceutical company is hiring an Associate Scientist/Engineer. Please ONLY local candidates to Summit NJ. Work Schedule: Wed-Sat- (7am-5pm) EST. MUST have 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. MUST have relevant work experience, preferably in a health authority regulated environment.
Work Location: Summit NJ
Pay: $46-48/hour W2
Required Skills:
• Responsible for leading investigation reports in support of S12 CAR T operations
• This includes execution of thorough root cause investigations, interviewing personnel,
hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive actions (CAPA), and troubleshooting complex problems
• 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) or Infinity
• Hands on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality
Control
• Requires a Bachelor’s Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred)
• Previous experience working in a biopharmaceutical manufacturing
facility is preferred (CAR T a plus)
• Conduct thorough investigations (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
• May travel between NJ sites for training, meetings or corporate events on
occasion
• Will need to have flexibility to work extended hours (>8 hours/day),
weekend and/or holidays when required to meet deadlines
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