Insight Global

Compensation

Full Description

Must Haves: • Bachelor's Degree in related field • 3-5 years of experience in deviations investigations in pharmaceutical or biotechnology industries • Ability to reach and interpret documents such as: safety rules, operating and maintenance instructions, procedure manuals, test methods, and SOPs • Proven experience writing routine reports and correspondence Job Description: Insight Global is seeking a Deviation Investigator for a large biopharmaceutical client in the Raleigh-Durham area. 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. 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.