Aseptic Filling Operator II (2nd Shift)- $500 Sign On Bonus

SUMMARY:

All Production Line Operators are responsible for all activities associated with the manufacturing and filling operations, required to produce sterile drug products under aseptic conditions.

ESSENTIAL FUNCTIONS:
Include the following. Other duties may be assigned.
  • Compliance with associated SOPs and training requirements
  • Maintain aseptic gowning qualifications. NOTE: Must have flexibility, discipline and not fall out of established limits.
  • Obtain requirements for media qualification
  • Basic understanding of aseptic procedures, aseptic connections and cleanroom behavior in controlled environments
  • Knowledge of documentation activities in log books, forms etc. in a legible manner as per cGMP
  • Qualify to perform Rodac sampling of aseptic personnel during fills
  • Basic understanding of personnel, equipment flow and controlled environments
  • Post filling/bubble point testing of filters (Vispro vent and solution filling filters)
  • Cleaning of Kettle 1, Waukesha, Thokem and associated piping components. (Some lifting required, up to 50 lbs.) Any object greater than 60 pounds, not to exceed 100 lbs. must require the use of a buddy system. This system requires two employees to lift the object. No employee can lift any object greater than 50 lbs by themselves.
  • Collection of Kettle #1 samples
  • Assist (as second operator) in operating Kalix and Chase in reloading components, cap/tip jams in bowl/live track, and changing the Vispro cans.
  • Assembly of Vispro cans prior to sterilization
  • Ability to sanitize outside the aseptic core and fill log books correctly
  • Ability to train Production line Operator I.
  • Must be detail oriented with the ability to work within a team environment or independent if required.
  • Some Saturdays,Sunday and additional hours in weekdays(Overtime) will be required to work by the company based on the department’s schedule.
  • Must assume any position required within the department for coverage.
  • Must be able to work until all cleaning activities are complete.
  • Must be flexible in adapting to a work schedule that could change as a result in business direction.


ADDITIONAL RESPONSIBILITIES:

Must coordinate with packaging dept. senior operators to ensure all production activities are performed and production demands are satisfied.

Company
Akorn, Inc
Posted
09/12/2021
Type
Full time
Location
Franklin Township, NJ 08873, US