Associate Scientist

Summit, New Jersey

Job Title: Associate Scientist

Location: 100% Onsite at New Jersey

Work Schedule: Wed-Sat- (7am-5pm) EST
  
Responsibilities:  

  • 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. Notify stakeholders of any delays in a timely manner.
  • Provide technical support for manufacturing investigations / CAPAs / change controls as needed.

 
Required Skills:  

  • Requires a Bachelor’s Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred).
  • Minimum 1 year 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.

About SSi People: 
With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well. 

 

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