Qc Investigation Support Specialist

Johnson & Johnson

Raritan, New Jersey, United States of America
Base: $65,000.00 - $104,650.00; bonus/equity: not ...
Onsite
Bachelor's degree required
Two years qc laboratory experience
Knowledge of cgmp and fda guidance
Johnson & Johnson is seeking a QC Investigation Support Specialist for their Innovative Medicine division in Raritan, NJ. The role involves investigating deviations in Quality Control laboratories for cell therapy products, ensuring compliance with regulatory standards, and contributing to high-quality patient care

Job Summary

  • The role involves investigating deviations to support Quality Control testing laboratories for cell therapy products used in clinical trials and commercial operations.
  • Candidates must apply strong technical writing skills to draft clear, concise deviation and investigation documentation while collaborating with cross-functional teams.
  • Employees are eligible for comprehensive benefits including a 401(k) savings plan, up to 120 hours of vacation time, and 13 days of holiday pay.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a QC Investigation Support Specialist for their Innovative Medicine division in Raritan, NJ. The role involves investigating deviations in Quality Control laboratories for cell therapy products, ensuring compliance with regulatory standards, and contributing to high-quality patient care.

Salary

Base: $65,000.00 - $104,650.00; Bonus/Equity: Not specified; Benefits: 401(k), Vacation, Sick time, Holiday pay, Parental Leave

Skills & Requirements

Must-have

  • Bachelor's degree required
  • Two years QC laboratory experience
  • Knowledge of cGMP and FDA guidance
  • Proficient technical writing skills
  • Experience with deviation investigations

Nice-to-have

  • Cell therapy QC assay knowledge
  • Familiarity with QEM systems
  • Compendial standards knowledge
  • Inspector interaction experience
  • Cross-functional presentation skills

Key Requirements

  • Minimum Bachelor's degree
  • Minimum two years relevant work experience
  • Knowledge of Good Documentation Practices
  • Ability to accommodate shift schedule and overtime

Work Rights

Not specified

Tailored Resume

Cover Letter