Job title: Viral Inspection II (2nd shift)

Duration:

1 year

Location:

Swiftwater, PA Shift 2nd: 2pm to 10:30 pm est Work Schedule B37/B57

Evening Job 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. Reliability/Flexibility

• you are expected to be on time (at your shift huddle at the start of your shift) and be here on your scheduled days, unless approved by your supervisors and managers.

Note:

Call in's

• the expectation is to give as much notice as possible even in an emergency situation. If there are planned days needed, then this must be reviewed and approved by your supervisor and manager more than 2 days in advance. Overtime may be asked of you. Scheduled days off may change. Backup plans to accommodate schedule changes will be helpful. Integrity
• Can work in a team environment; can share knowledge and ideas with peers and above; has positive interactions with others and is not afraid to ask questions. Is willing to receive feedback for further improvement of oneself. Is motivated and is willing to help. Attention to detail
• not only regarding the process and documentation but also has awareness of the surroundings regarding the equipment (example: light out at your home).

Working safely on the job and adhering to all personal protective equipment requirements.

Requirements/Responsibilities:

?Lift a minimum of 30 pounds, and be able to push and pull a minimum of 50 pounds ?Ability to follow Standard Operating Procedures and Standard Work Instructions. Each worker must be able to track their own training and can only work on tasks they are qualified to perform. ?Good reading and writing skills. Documentation is critical and a cGMP requirement. ?Able to sit or stand for long periods of time ?Passing all exams and qualification tests ?Ability to concentrate for long periods of time ?Must produce high quality work. ?Can work in an ever changing, semi-fast paced environment, focus on task, maintain safety and quality ?Must be able to work under tight deadlines and strict processes and adhere to compliance rules and regulations. ?Basic computer skills, with an emphasis on digital documentation skills. ?Each task within the Department requires specific training. Each worker must be able to track their own training and can only work on tasks they are qualified to perform. ?Must have ability to stack material 4

• 6 feet high.

•

Aptitude Test:

critical thinking and reject re-classification Every employee must be able to work weekends, holidays and overtime depending on business need. Everyone is scheduled two days off, but days off may not be consecutive and may vary from week to week (rotating schedule). Jewelry and makeup are not allowed on the floor. Perfume, hairspray, cologne, aftershave and/or any scents are not permitted. Long fingernails, fake fingernails and any kind of nail polish are not allowed. Don't come to work sick. Cell phones are also not allowed on the production floor. Drug free environment. Must follow Drug policy requirements Zero tolerance for workplace harassment. The attire includes sterile scrubs and gowns, hairnets, beard covers, safety glasses and steel toe boots. There may be extended gowning for higher grade areas.