Sr. Investigator

Merck•Indianapolis, IN

3d•Onsite

About The Position

Reports to QMS Manager and Quality Systems Team. The Sr Deviation Investigator is responsible for providing timely resolution of assigned deviations and complaints, 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.

Requirements

Bachelor’s degree in a science or engineering field
Minimum of 5 years of experience required in a pharmaceutical manufacturing site environment
At least 2 of those years directly supporting deviation investigations

Nice To Haves

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

Responsibilities

Process deviations and complaints within the quality management system and conduct thorough root cause investigations.
Interviewing personnel involved and interacting with technical support and other personnel to determine root causes of the deviations and to assess impact.
Reviewing instructions, reference material, and documentation to understand the processes being investigated and what went wrong.
Track deviations for area assigned to help ensure on-time completion of each step.
Tracking and completing deviation investigations for areas assigned and assisting manager in improving the quality of investigations.