35 applicantsPosted by Agency
TSR Consulting Services, Inc. · 2 days ago
Associate Scientist/Engineer
Summit, NJ
Contract
Onsite
Mid Level
$46/hr - $48/hr
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Responsibilities
Responsible for leading investigation reports in support of S12 CAR T operations
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
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
Qualification
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Required
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
Ability to collaborate effectively in cross functional teams
Relevant work experience, preferably in a health authority regulated environment
Responsible for leading investigation reports in support of S12 CAR T operations
Proven ability to accurately and completely understand, follow, interpret, apply Global Regulatory and cGMP requirements
Ability to support health authority inspections
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
Will need to have flexibility to work extended hours (>8 hours/day), weekend and/or holidays when required to meet deadlines
Preferred
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
May travel between NJ sites for training, meetings or corporate events on occasion
Company
TSR Consulting Services, Inc.
TSR is a relationship-based, customer-focused IT and technical services staffing company. For over 50 years TSR, Inc.
Founded in 1969
501-1,000 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown2012-08-20IPO· nasdaq:TSRI
Leadership Team
Thomas Salerno
CEO
Company data provided by crunchbase
