Packaging and Control Operator - Bulk Vials

O

Ompi of America Inc

Posted 3 months ago

Full Time

Fishers, Indiana

In Person

Smart Summary

Responsibilities

Perform visual, dimensional, and functional controls on manufactured products according to the control plan. Execute primary and secondary packaging activities and manage raw material supply within a clean room environment.

Qualifications

You will perform visual, dimensional, and functional controls on manufactured products and engage in sorting and reworking activities. You will also be responsible for primary and secondary packaging, supplying raw materials, maintaining cleanliness, and accurately recording control results in the company's software and forms.

Must Have Skills for ATS

MS Office

Teams

LIMS

ERP

Job Description

This position will be required to travel to Italy for no more than 3 months for Bulk Vials training. Please do not apply unless able to travel. After travel, this role will be onsite: Monday-Friday from 8am-5pm. 

Mission 

Perform visual, dimensional, and functional controls according to the control plan of the manufactured product. Sorting and reworking activities. Primary and secondary packaging activities. 

Key Accountabilities / Decisions Area

CONTROL, SORTING, & REWORKING 

• Perform the visual, dimensional, and functional controls according to the control plan of the manufactured product. 

• Perform the sorting and reworking activities linked to a non-conformity. 

PACKAGING 

• Perform the primary and secondary packaging activities in compliance with the product master specification, manually or using the dedicated packaging equipment. 

RAW MATERIALS SUPPLY 

• Supply the raw materials needed for the production, carrying them from the Clean Room Airlock to the Production Line. Perform the materials movement according to the related safety rules. 

CLEANING 

• Guarantee a high level of cleaning and tidiness of the working areas. 

RECORDING 

• Recording the controls results and the other required information in the dedicated software and/or forms. 

• All employees are expected to comply with all safety requirements promoting a Safety First culture striving for an injury free workplace. 

• PPE such as Safety glasses, safety shoes, hearing protection, and gowning required in designated areas. 

• Tasks may include standing, walking, bending, and sitting. Training • Internal QMS training 

• Relevant training on use of IT tools (i.e. MS Office, Teams, LIMS, ERP, and other company applications) 

• Corporate prescribed safety training. 

The essential functions and physical requirements of this position are as follows: 

Physical Activities: 

  • Ability to sit or stand for up to 8 hours per day. 
  • Frequently bend, twist, and reach or extend as part of daily activities. 
  • Lift, carry, and move items weighing up to 20 pounds as needed. 

Visual and Inspection Requirements:

  • Must have 20/20 vision (natural or corrected) to perform visual inspection of manufactured products for quality and compliance with specifications. 

Technical and Office Duties: 

  • Regularly read and interpret technical documents and specifications. 
  • Operate a computer and other office equipment as necessary. 
  • Occasionally work in an office environment to complete administrative or technical tasks.

O

Ompi of America Inc

Founded in 1949, Stevanato Group is one of the world's largest providers of integrated containment and delivery solutions for the biopharmaceutical industry. From the beginning, the Group has developed its own glass forming technology to ensure quality of the highest standards. The Group includes a wide range of skills dedicated to serving the biopharmaceutical and diagnostic industry. It offers glass containers with its historic Ompi brand, plastic components for diagnostics and medical devices, contract manufacturing services for drug delivery systems, up to inspection, assembly and packaging machines. The Group also provides analytical services and tests that study the interaction between container and drug and integration into delivery sys-tems, supporting the drug development process. By bringing together several skills under the same entity, Stevanato Group is able to offer unique solutions to companies by reducing the time to market and the overall cost.
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