Job Description :SUMMARY
Under the general supervision of the Supervisor, Aseptic Core Monitoring, 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 fills, lyophilizer loading/unloading, and sanitization processes.
- Communicate openly to all personnel in the aseptic core to provide feedback and mentoring regarding observed performance.
- Take immediate 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.
- 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.
- 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.
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
- Aseptic Processing experience, including proficiency in Aseptic Gowning qualifications is desirable.
- The ability to gown and work daily 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 â€regularâ€ 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.
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 company information as required
Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.EEO Statement
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
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