Senior Investigator

4 weeks ago


Mount Holly Springs, Pennsylvania, United States FUJIFILM Corporation Full time
About This Role

The Senior Investigator of Deviations Management for Drug Substance Manufacturing (DSM) plays a critical role in ensuring the quality and integrity of our manufacturing processes.

Key Responsibilities
  • Conduct thorough investigations of deviations and non-conformities, identifying root causes and implementing corrective actions.
  • Develop and implement effective procedures for deviation management, ensuring compliance with regulatory requirements.
  • Collaborate with cross-functional teams to identify and mitigate risks, ensuring the highest level of quality and safety.
  • Provide training and guidance to junior investigators, promoting a culture of quality and excellence.
  • Communicate effectively with senior leadership and stakeholders, providing updates on investigation progress and outcomes.
Requirements
  • High school diploma or equivalent, with 12 years of related experience.
  • Associate degree in Life Sciences or Engineering, with 10 years of direct experience, or Bachelor's degree in Life Sciences or Engineering, with 8 years of direct experience.
  • Prior experience in quality or manufacturing operations, with a focus on deviation management and root cause analysis.
Working Conditions

The Senior Investigator will work in a fast-paced manufacturing environment, with a focus on ensuring the highest level of quality and safety.

The ideal candidate will possess excellent communication and interpersonal skills, with the ability to work effectively in a team environment.

FDBN is an Equal Opportunity Employer, committed to diversity and inclusion in the workplace.



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