Operations Compliance Specialist

Catalent, Inc.

San Diego, California, US
Base: $75,000 to $85,000 annually; bonus/equity: p...
Bachelor's degree in science or engineering
5 years cgmp industry experience
3 years technical writing in gmp
The Operations Compliance Specialist ensures patient safety and regulatory compliance by leading investigations and managing deviations within a cGMP environment

Job Summary

  • The Operations Compliance Specialist ensures patient safety and regulatory compliance by leading investigations and managing deviations within a cGMP environment.
  • Candidates will utilize Lean and Six Sigma tools to drive root cause analysis and develop Standard Operating Procedures to strengthen operational standards.
  • The role offers competitive benefits including medical, dental, vision effective day one, 152 hours of PTO plus 10 paid holidays, and tuition reimbursement.

Matching Summary

The Operations Compliance Specialist ensures patient safety and regulatory compliance by leading investigations and managing deviations within a cGMP environment.

Salary

Base: $75,000 to $85,000 annually; Bonus/Equity: Potential for bonus; Benefits: Medical, dental, vision, 401K match, 152 hours PTO + 10 holidays

Skills & Requirements

Must-have

  • Bachelor's degree in Science or Engineering
  • 5 years cGMP industry experience
  • 3 years technical writing in GMP
  • Strong Microsoft Office and Excel skills
  • Ability to lift up to 35lbs

Nice-to-have

  • Lean Six Sigma certification
  • Knowledge of JD Edwards 9.2 systems
  • Experience with TrackWise or ComplianceWire
  • Cross-functional problem-solving facilitation
  • Dynamic pace working environment

Key Requirements

  • Bachelor's degree required
  • Minimum 5 years cGMP experience
  • Minimum 3 years technical writing experience
  • Lean Six Sigma certification preferred

Work Rights

Not specified

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