Winston-Salem Metro Area, NC
The deviation owner will lead the investigation of deviations that occur in operations and are responsible for authoring the investigation. Partners with quality assurance, quality control, operations, engineering, maintenance, calibration, safety and supplier quality management to ensure appropriate and timely determination of scope, product impact, root cause and corrective actions. Interacts will all levels of staff and provides status updates as well as present the strategy for closure of deviations. Manage several investigations at a time. Determine scope, product impact, root cause and corrective actions for deviations from manufacturing procedures. Determine appropriate preventative actions to prevent reoccurrence of the deviation, author deviations and conduct personnel interviews to determine root cause of the deviation. Author and manage the investigations to meet key timing commitments, with well-investigated and well-documented deviation reports. Work with the Technical Services, Subject Matter Experts and Quality Approvers to determine the breadth and scope of the investigation to identify the appropriate root cause, implement corrective actions, complete trending analysis, and recommend product disposition.
3-5 years of deviation, investigative writer experience. Experience in a regulated environment such as medical devices, pharmaceuticals or biotech industry. Must have a thorough understanding of the pharmaceutical/biotech manufacturing process and equipment, preferably solid oral dosage, and current Good Manufacturing Practices (cGMPs). Must have good analysis, troubleshooting, and investigation skills.
BA/BS science preferred.