Manufacturing Specialist, Upstream Job at KBI Biopharma in Durham

Position Summary The incumbent will support GMP manufacturing operations for late-phase and commercial mammalian Cell Culture programs and oversee compliance activities for the department. The individual will support operations during the planning stages by releasing electronic manufacturing logbooks and records, as needed. The employee will support operations during the execution stage by tracking manufacturing records and logbooks in execution. They will also support manufacturing record and logbook reviews and track them through their post-execution life cycle. The individual will monitor GDP execution and provide feedback, coaching, and training to ensure ‘Right the First time’ execution of manufacturing documentation. They will also track metrics for executed manufacturing records and logbooks throughout their entire lifecycle. This person will also ensure the manufacturing training plan is set appropriately and track training metrics and compliance for the department. The individual will oversee the departmental compliance activities and metrics as it pertains to deviations, CAPAs, and change controls. They will initiate and complete deviations, CAPAs, and change controls, as needed, to support operations. Lastly, the individual will author, train, and review manufacturing procedures as needed and perform additional duties as assigned. Position Responsibilities Release electronic manufacturing records and logbooks. Perform reviews of electronic logbooks and manufacturing records. Prepare and track departmental manufacturing records and logbooks throughout entire lifecycle and support executed record reviews and comment resolution. Author, train, review manufacturing procedures. Oversee and execute against departmental compliance activities associated with QA Systems such as deviations, CAPAs, and change controls. Develop and oversee manufacturing training plan, and training compliance for department. Other duties as assigned. Position Requirements Bachelor’s degree in a related scientific or engineering discipline preferred and 2-4 years’ experience for specialist in related GMP manufacturing operations or QA; or 4-6 years’ experience with a high school degree, or equivalent. Demonstrated knowledge of cell culture or fermentation unit operation is preferred. Experience in single-use platform technology is preferred. Excellent written and verbal communication skills are required. Strong attention to detail, as well as, presentation, written, and verbal communication skills required. Energetic, motivated and dynamic individual. Must be organized and able to focus in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor. Experience working with electronic QA Systems such as documentation, deviations, CAPAs, and change control systems is preferred. #J-18808-Ljbffr