The Aseptic Core Monitor II 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.
- Bachelor Degree in Scientific Discipline required.
- 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 adapt to a changing environment and handle multiple priorities.
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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