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Junior Research Scientist

2 months ago


Summit, New Jersey, United States Crox Consulting Inc Full time
Job Overview

Position Title: Associate Scientist

Company: Crox Consulting Inc

Location: Summit, NJ


Key Responsibilities:
  • Conduct comprehensive investigations related to environmental monitoring and deviations, employing root cause analysis methodologies.
  • Lead cross-functional teams in investigations and ensure timely closure of reports.
  • Perform GEMBA walks with stakeholders to gain insights into process steps and evaluate root causes.
  • Collaborate with functional teams to propose effective Corrective and Preventive Actions (CAPAs), develop CAPA plans, and ensure their effectiveness.
  • Assess potential impacts and risks associated with changes to products or processes and devise appropriate mitigation strategies.
  • Initiate change control documentation and identify subject matter experts for impact assessments as part of the change management process.
  • Ensure prompt completion of all investigations and communicate any delays to stakeholders.
  • Provide technical support for manufacturing investigations, CAPAs, and change controls as required.
  • Support deviation investigation defense during regulatory audits and site inspection inquiries.
  • Address complex issues and resolve problems with minimal supervision.
  • Serve as an author or technical reviewer for departmental procedures as necessary.
  • Utilize lean manufacturing and Six Sigma principles to drive continuous improvement in products, processes, and systems.
  • Support the organizational mission of prioritizing patient needs and fostering a 'Right First Time' mindset.

Qualifications:

Education: A Bachelor's Degree in a scientific or engineering discipline, preferably in Biochemistry, Life Sciences, or a related field (advanced degree preferred).

Experience: A minimum of 1 year of relevant experience, ideally in a regulated environment. Previous experience in a biopharmaceutical manufacturing facility is advantageous.


Working Conditions:

The role involves working primarily in an office environment, with some time spent in manufacturing or laboratory settings. Flexibility to work extended hours, weekends, or holidays may be required to meet project deadlines.


Additional Information:

This position requires 100% onsite presence.

Work Schedule: Wednesday to Saturday, 4 PM to 2 AM EST.

A Bachelor's degree is mandatory. The duration of this position is 6 months, with the possibility of extension based on performance.