What are the responsibilities and job description for the Deviation Investigator position at KBI Biopharma?
Job Summary
The deviation investigator, senior and principle deviation investigator supports Manufacturing operations. The investigator will independently conduct efficient and thorough investigations of deviations that occur in Manufacturing (or related areas, Supply Chain, IT), perform root cause analysis and contribute to developing appropriate Corrective and Preventative Actions designed to adequately address and correct the deficiencies identified during the investigation process. The investigator will complete the investigations and CAPAs in alignment with established procedures and timelines. Analyze trends and develop effective preventive actions to minimize the potential for repeat incidents. Provide technical assistance to technical leaders to solve complex problems.
Additionally, experience using single use equipment and an understanding of upstream, downstream and / or manufacturing support biotechnology
principles is desired.
Must have excellent critical thinking skills, ability to analyze, interpret, and clearly present complex problems with conclusions and understanding of the impact to the product. The role requires excellent writing skills with full grasp of grammar, spelling and style rules, compliance with quality standards guidelines and factual accuracy. Additionally, staff may assist with change controls, as well as with personnel training, inspection preparation activities, continuous improvement efforts to increase process robustness and efficiency. Senior and Principal investigators will be required to become qualified trainers. Principal investigators will be required to become mentors for other trainee deviation investigators. Principal investigators would act as manager’s designee when manager is unavailable. Staff may represent KBI and its programs with regulatory agencies as well as business partners.
Job 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.
