Sr. Investigator

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
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.
Major Position Activities & Responsibilities:
Deviation Investigation:
Process deviations and complaints 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.
Scope:
Tracking and completing deviation investigations for areas assigned and assisting manager in improving the quality of investigations.
Who You Are
Minimum Qualifications:
Bachelor’s degree in a science or engineering field
Minimum of 5 years of experience required in a pharmaceutical manufacturing site environment with at least 2 of those years directly supporting deviation investigations
Preferred Qualifications:
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
Pay Range for this position: $104,100- $156,100 / year​
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other prerequisites. For more information click here.