Description:
Employees will inspect vials and/or syringes containing the active pharmacological ingredient (i.e. Vaccines) using an automated process and a manual process. The automated process requires personnel to be on their feet and be able to move product (trays/tubs/totes) from the ground level to waist height several times.
The manual process will be completed from a sitting position only at a bench, with 20/20 vision with or without prescribed corrective lenses. The bench work will inspect for proper final container closure which includes levels, cosmetic defects, foreign objects and particulates. Manual inspection bench work requires long periods of time in which you need to focus and concentrate to accurately assess the vial/syringe.
Both roles require movement of materials (i.e. carrying an empty pallet), moving carts and may include the use of a pallet jack. Inspection also requires ongoing training classes and assessments throughout the assignment. There is also extensive documentation, as well as following strict Standard Operating Procedures (SOP’s), Standard Work Instructions (SWI) and FDA guidelines. This person will maintain good housekeeping of work area and public spaces. Good personal hygiene practices must be followed in an aseptic environment. Sharing locker space is probable.
The on-boarding training process will take weeks of dedicated learning and qualification testing, which requires a passing score to work in this department. Passing Tests for: 1) cGMp test 2) Eye test 3) Bench test sets 4) Tests associated with your assigned training modules.
Constant communication with training coordinators and managers will be necessary to ensure timely completion of your training. Ownership of your development and position training is expected.
Note: Call in’s – the expectation is to give as much notice as possible even in an emergency situation.
Requirements/Responsibilities: