Under the general supervision of the Director, Microbiology, the Supervisor, Aseptic Core Monitoring oversees the aseptic core monitoring program and departmental personnel. The Supervisor, Aseptic Core Monitoring develops and implements procedures to the Aseptic Core Monitoring program. This position oversees the Aseptic Core Monitors who review all activities in the aseptic environment to ensure continued compliance with cGMP and leads the mentoring program surrounding aseptic technique for all aseptic personnel. This position requires expertise in all aspects of product manufacturing, 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.
Oversee audit program of Aseptic Behavior inside the core during fills, lyophilizer loading/unloading, and sanitization processes.
Leads open communication to all personnel in the aseptic core to provide mentoring regarding observed performance.
Ensures immediate action is taken when non-compliance and/or undesired behavior by personnel in the facility is observed.
Coordinates corrective action training based on visual audits by providing immediate feedback.
Leads program of partnering with Operations/Quality/Training Leadership to make recommendations for enhancements to aseptic process.
Oversees daily inspection program of the physical conditions of the aseptic core.
Review aseptic technique associated with media fill program.
Routine presence in the Aseptic Core is required.
Responsible for leading personnel training in Aseptic Techniques and processes.
Reports metrics and trends to site management on a regular basis.
Assumes additional duties and responsibilities as assigned.
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
Bachelor Degree in Scientific Discipline, preferably Microbiology, or equivalent combination of education and experience
3-5 yrs experience working in a sterile pharmaceutical manufacturing environment.
2 yrs Aseptic Processing experience, including proficiency in Aseptic Gowning qualifications is required.
1+ yrs supervisory experience is strongly preferred.
The ability to gown and work in an aseptic manufacturing environment.
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 get the required tasks accomplished to meet deadlines.
Have a thorough knowledge in applicable FDA/cGMP guidelines related to Aseptic Processing.
Ability to present results and interface with senior level management.
Safety glasses and safety shoes. The ability to gown and work safely in an aseptic manufacturing environment.
PHYSICAL DEMANDS AND WORK ENVIRONMENT:
While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use.
Mental Requirements include:
Ability to hear accurately the spoken word with moderate office noise or plant noise
Ability to apply deductive reasoning and understand complicated issues
Ability to receive instructions and follow work rules and company policies
Ability to follow safety and security practices
Ability to meet deadlines and effectively deal with stress
Ability to accurately communicate ideas, facts and technical information
Maintain confidentiality of certain information