Manufacturing Principle Investigator I

American Regent Inc

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Investigate non-routine events
Cgmp manufacturing
Sterile pharmaceuticals
** American Regent Inc. is seeking a Manufacturing Principal Investigator I to oversee investigations related to the production of sterile pharmaceuticals. The ideal candidate should have experience in an FDA-regulated environment, strong problem-solving skills, and the ability to work independently. **

Job Summary

  • As a member of the Manufacturing department, the Principal Investigator I ensures any non-routine events associated with the manufacture of safe, pure, and effective sterile pharmaceuticals are investigated and documented in accordance with company SOPs, policies, and cGMPs.
  • This position generates investigation summaries for all departments within the facility and may include data compilation and evaluation, impact assessments, root cause analyses, and corrective/preventive actions.
  • The Principal Investigator I also has a critical role in maintaining production schedules and meeting Company goals.

Matching Summary

Match Score: 75

** American Regent Inc. is seeking a Manufacturing Principal Investigator I to oversee investigations related to the production of sterile pharmaceuticals. The ideal candidate should have experience in an FDA-regulated environment, strong problem-solving skills, and the ability to work independently. **

Skills & Requirements

Must-have

  • investigate non-routine events
  • cGMP manufacturing
  • sterile pharmaceuticals
  • root cause analysis
  • corrective/preventive actions
  • process and performance metrics

Nice-to-have

  • technical writing skills
  • problem solving skills
  • feedback constructively
  • team oriented work environment

Key Requirements

  • Minimum 1 year experience
  • Bachelor’s degree preferred
  • Intermediate MS Word and MS Excel skills
  • Work independently with minimal supervision

Work Rights

Not specified

Tailored Resume

Cover Letter