Compliance Specialist

2 weeks ago

Durham, North Carolina, United States KBI BioPharma Full time
Job Title: Compliance Officer

The Manufacturing Compliance Specialist will play a crucial role in supporting GMP manufacturing operations for late-phase and commercial mammalian Cell Culture programs. This position will oversee compliance activities for the department and provide support in the following areas:

Key Responsibilities:
  • Support Operations during the planning stages by releasing electronic manufacturing logbooks and records, as needed.
  • Support Operations during the execution stage by tracking manufacturing records and logbooks in execution.
  • Support manufacturing record and logbook reviews and track them through their post-execution life cycle.
  • Monitor GDP execution and provide feedback, coaching, and training to ensure 'Right the First time' execution of manufacturing documentation.
  • Track metrics for executed manufacturing records and logbooks throughout their entire lifecycle.
  • Ensure the manufacturing training plan is set appropriately and track training metrics and compliance for the department.
  • Oversee the departmental compliance activities and metrics as it pertains to deviations, capas, and change controls.
  • Initiate and complete deviations, capas, and change controls, as needed, to support operations.
  • Author, train, and review manufacturing procedures as needed and perform additional duties as assigned.
Requirements:
  • Experience in production or quality assurance of GMP manufacturing is required.
  • Experience working with electronic quality management systems such as documentation, deviations, capas, and change control systems is preferred.
  • Experience working with electronic manufacturing records or logbooks is preferred.
  • Experience working in biopharmaceutical manufacturing 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 face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.

Shift: M-F 7am-7p

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

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