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Associate QC Scientist

Summit, NJ 07901

Posted: 01/18/2024 Job Number: 26120596 Pay Rate: 45.0-49.09 USD/Hour

Job Description

100% Onsite.
The pay ranges between $45 - $49.09 per hour.

Project Description:
  • The Associate Scientist/Engineer is 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.
  • The successful incumbent must interface closely with different functional organizations, including Quality Assurance teams.
  • 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.
  • Support deviation investigation defense during audits and site inspections related inquiries.
  • Handle complex issues and solve problems with minimal guidance.
  • Serve as author or technical reviewer of departmental procedures as appropriate.
  • 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.

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).
  • An equivalent combination of education and experience may substitute.
  • 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.
  • Demonstrate advanced problem-solving ability / mentality, technical adeptness, and logical thinking.
  • Ability to set priorities, manage timelines and effectively react/manage changing priorities.
  • Ability to work with management (global and site) and support corporate and departmental goals.
  • Ability to communicate honestly, transparently, and effectively with peers, department management and cross functional peers.
  • 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.

Working Conditions (US Only):
  • The incumbent will be working 80% to 90% of the time in an office environment.
  • The incumbent will be working 10% to 20% of the time in a manufacturing and/or laboratory setting.
  • The incumbent may travel between NJ sites for training, meetings or corporate events on occasion.
  • The incumbent will need to have flexibility to work extended hours (>8 hours/day), weekend and/or holidays when required to meet deadlines.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Rose: Rose@alphaconsulting.Com


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Rose Minchello

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