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Sr. Investigator

Merck Group
Indianapolis, United Statesfull_timeVerifiedPosted 18 Jul 2024

About the role

 

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

 

Position Overview:

  • The Sr Deviation Investigator is responsible for providing timely resolution of assigned deviations, ensuring that the investigations are thoroughly investigated to determine root cause, and that robust CAPA’s are implemented whenever necessary. The investigator will be assigned specific areas for which they will be responsible for deviation investigation.
  • The investigator will coordinate with the area, technical support, and other personnel to facilitate completion of deviation investigations.
  • The investigator will keep track of deviations for assigned area(s) and help to ensure deviations are evaluated and closed per timing requirements.
  • Sr Deviation Investigators are generally assigned the more complex deviations as they require more experience and coordination to complete investigation.

Major Position Activities & Responsibilities:

  • Deviation Investigation:

Process deviations within the quality management system and conduct thorough root cause investigations. This will require interviewing personnel involved and interacting with technical support and other personnel to determine root causes of the deviations and to assess impact.  Deviation investigation will also require reviewing instructions, reference material, and documentation to understand the processes being investigated and what went wrong.

  • Deviation Tracking:

Track deviations for area assigned to help ensure on-time completion of each step.

  • Training and Quality of Investigations

Assist manager in developing processes and delivering training to improve the quality of non-conformance documentation and investigations.

Scope:

  • Tracking and completing deviation investigations for areas assigned and assisting manager in improving the quality of investigations.

Background Qualifications:

  • Bachelor’s degree in a science or engineering field
  • Minimum of 8 years of experience required in a pharmaceutical manufacturing site environment with at least 3 of those years directly supporting deviation investigations
  • Advanced user of Microsoft Office products, including Excel, Word, Access, and PowerPoint
  • Use and system knowledge and experience of Quality Management Systems
  • Ability to interface with personnel from multiple areas to deliver results (e.g., complete deviation investigation)
  • Demonstrated ability to write through, clear, concise, and logically organized technical documents

     

    Position Overview:

  • The Sr Deviation Investigator is responsible for providing timely resolution of assigned deviations, ensuring that the investigations are thoroughly investigated to determine root cause, and that robust CAPA’s are implemented whenever necessary. The investigator will be assigned specific areas for which they will be responsible for deviation investigation.
  • The investigator will coordinate with the area, technical support, and other personnel

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Company

Merck Group

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