Aseptic Core Monitor (Vineland)

Compensation

: $32,750.00 - $47,810.00 /year *

Employment Type

: Full-Time

Industry

: Pharmaceutical/Biotechnology



Loading some great jobs for you...





You are invited to the Akorn Job Fair: Friday, December 6th, 2019 at the Somerset NJ Doubletree Hotel. Please RSVP to ...@akorn.com.

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 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.

ESSENTIAL FUNCTIONS:

  • Complete daily visual audits of Aseptic Behavior inside the core during fills, and sanitization processes.
  • Communicate openly to all personnel in the aseptic core to provide 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 process.
  • 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.
  • Qualifications

    EDUCATION AND EXPERIENCE :

  • Excellent oral and written communication skills
  • Bachelor Degree in 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 in an aseptic manufacturing environment.

  • JOB PREREQUISITES:
  • 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.
  • You are invited to the Akorn Job Fair: Friday, December 6th, 2019 at the Somerset NJ Doubletree Hotel. Please RSVP to ...@akorn.com.
    Associated topics: assembler, ear piercing, manufacturing, pharmacy technician, service porter, service support, tech, technician, technician staff, wire * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

    Launch your career - Create your profile now!

    Create your Profile

    Loading some great jobs for you...