Senior Deviation Investigator

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

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

Experience using single-use equipment
Understanding of upstream, downstream and/or manufacturing support biotechnology principles