Viral Inspection II (2nd shift)

Spectraforce Technologies, Inc.; Swiftwater (Monroe County); Sur place; USD 25 000 - 30 000; Plein temps

Résumé du poste

Spectraforce Technologies, Inc. seeks a Viral Inspection II for a 12-month assignment in Swiftwater, PA. You will inspect vials/syringes using automated and manual methods, follow cGMP SOPs, and maintain training compliance.

The role requires physical ability to lift 30 lbs, push/pull 50 lbs, and stand/walk long shifts, with weekend/work overtime as needed. You will work in a sterile environment with strict quality and safety standards.

Qualifications

• Experience reading/writing required; documentation is critical (cgmp).
• Ability to follow SOPs and standard work instructions.
• Must be able to lift 30 lb, push/pull 50 lb, stand or sit for long periods.
• Basic computer literacy and digital documentation skills required.

Responsabilités

• Inspect vials/syringes using automated and manual processes.
• Adhere to cGMP, SOPs and training requirements; track own training.
• Move materials and operate pallet jacks as needed.
• Maintain high quality, accurate documentation and recordkeeping.
• Participate in qualification tests and shifts planning.

Connaissances

Reading & writing

SOP compliance

Physical stamina

Computer literacy

Training tracking

Teamwork

Description du poste

Viral Inspection II

Swiftwater, PA, 18370
12 months
Shift: 2nd (2 PM to 10:30 PM)

Note

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).

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.

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

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 Sanofi 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.

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.