Quality Assurance Coach (ACM) I - 3rd Shift (Sign-On Bonus $1000)
Akorn 2

Decatur, Illinois

Posted in Science and Research

This job has expired.

Job Info

Quality Assurance Coach (ACM) I - (3rd Shift Sun-Thurs 11p-8a)Sign-On Bonus $1000

The Quality Assurance Coach oversees all activities in the aseptic environment to ensure continual compliance with cGMP and provides mentoring on aseptic technique for all aseptic personnel.

  • 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.
  • 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's Degree in a scientific discipline, preferably Microbiology, or equivalent combination of education and experience 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 present results and interface with senior level management.
  • Thorough knowledge in applicable FDA/cGMP guidelines related to Aseptic Processing
*Apply by end of March 2022 to qualify for sign-on bonus

Company Overview
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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