Under the general supervision of the Manager, Quality Aseptic Operations, the Aseptic Core Monitor oversees all activities in the aseptic environment to ensure continual compliance with cGMP and provides mentoring on aseptic technique for all aseptic personnel. This position requires expertise in all aspects of aseptic manufacturing of sterile product, ability to work hands on, strong leadership skills, and the ability to collaborate in a cross-functional environment. The individual will work closely with all departments in the manufacturing environment and reports metrics to site management on a regular basis.
· Complete daily visual audits of aseptic behavior inside the core during set up, filling, lyophilizer loading/unloading, tear down, and sanitization processes.
· Communicate openly to all personnel in the aseptic core to provide real time feedback and mentoring regarding observed aseptic performance.
· Take immediate corrective and preventative action when non-compliance and/or undesired behavior by personnel in the facility is observed.
· Provide corrective action training based on visual audits by providing immediate feedback.
· Partner with Operations/Quality/Training Leadership to make recommendations for enhancements to aseptic processes and completion of required trainings.
· Complete daily inspections of the physical conditions of the aseptic core.
· Review aseptic technique associated with media fills and help complete documentation and final vial count verification as necessary.
· Perform other essential quality functions including, but not limited to: release to fill, release of cleaning agents, release of raw materials, and line clearance
· Daily presence in the Aseptic Core is required.
· Responsible for training personnel in Aseptic Techniques and processes.
· Reports metrics and trends to site management on a regular basis.
· Assumes additional duties and responsibilities as assigned.
· Ability to meet attendance standards. All full-time employees are required to work a 40-hour week, most of which has to be during “regular” business hours. At times it may be necessary to work additional hours, or shifts, in order to accomplish required tasks to meet deadlines and goals.
· Have a thorough knowledge in applicable FDA/cGMP guidelines related to Aseptic Processing.
· Ability to present results and interface with senior level management.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND EXPERIENCE:
· Excellent oral and written communication skills
· Ability to adapt to a changing environment and handle multiple priorities
· Bachelor Degree in Scientific Discipline, preferably Microbiology, or equivalent combination of education and experience
· Aseptic Processing experience, including proficiency in Aseptic Gowning qualifications is desirable.
· The ability to gown and work daily in an aseptic manufacturing environment.