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Senior Deviation Investigator
| Company | KBI Biopharma |
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| Location | Durham, NC, USA |
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| Salary | $84000 – $115000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s, Master’s |
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| Experience Level | Senior |
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Requirements
- BS/BA and minimum 1-5 years related industry experience or MS/MA for Deviation Investigator
- BS/BA and minimum 5 years related industry experience or MS/MA and minimum 2+ years related industry experience for Sr. Deviation Investigator
- Excellent critical thinking skills
- Ability to analyze, interpret, and clearly present complex problems
- Excellent writing skills with full grasp of grammar, spelling and style rules
- Understanding of upstream, downstream and/or manufacturing support biotechnology principles
Responsibilities
- Write and conduct quality control deviation investigations, including interviews and discussions with technical SMEs
- Gather information from all necessary internal and external sources to evaluate the impact of the deviation to the product as well as the risk to future operations
- Perform root cause and historical trend analysis and develop appropriate Corrective and Preventative Action (CAPA) to prevent deviation recurrence
- Initiate CAPA quality records, execute the process and follow-up on the implementation of the actions
- Act as an area/department representative in deviation discussions, coordinating activity and proposals with functional area approvers for both deviations and CAPAs
- Analyze deviation trends within Manufacturing department to aid into Risk Assessment and development of appropriate Preventive Actions in support of continuous improvement
- Support change controls, training, inspection preparation activities
Preferred Qualifications
- Experience using single-use equipment
- Understanding of upstream, downstream and/or manufacturing support biotechnology principles
