Assembler Associate II
Location: North Chicago, IL
Duration: 12 Months
Shift: 6:00 AM 2:30 PM
Job Summary
The Production Operator is responsible for production activities involving aseptic filling and label application of filled bottles/vials. Responsibilities include operating, setting up, shutting down, and cleaning filling equipment in an ISO 7 environment, as well as operating labeling and inspection equipment in an open-air Controlled Non-Classified (CNC) area.
The role requires extensive digital and hard-copy documentation, adherence to GMP requirements, safe equipment operation, housekeeping, and support of overall production activities. The ideal candidate can multitask, troubleshoot minor production issues, make decisions, and maintain product quality and GMP standards.
Key Responsibilities
- Follow established GMP procedures and instructions without deviation.
- Operate filling, labeling, and other production equipment.
- Set up, shut down, and clean production equipment.
- Operate multiple pieces of equipment simultaneously.
- Monitor production activities and clear minor equipment jams to minimize downtime.
- Report equipment malfunctions and product issues promptly.
- Accurately complete work orders and production documentation.
- Maintain accurate and legible records.
- Perform visual and physical inspection of products and materials.
- Perform basic mathematical calculations.
- Maintain and replenish production materials.
- Follow all safety procedures and report incidents, injuries, and hazards.
- Complete general housekeeping activities.
- Support team production goals and efficiency.
- Communicate effectively with team members and leadership.
- Use computer-based programs including Microsoft Office, SAP, and production-specific software.
Required Qualifications
- High school diploma or GED equivalent.
- Prior manufacturing experience in a GMP environment.
- Experience working in an environment adhering to ISO standards.
- Ability to gown properly for cleanroom environments, including hood, shoe covers, coveralls, etc.
- Ability to lift up to 20 lbs.
- Basic math skills, including addition, subtraction, multiplication, and division.
- Basic computer literacy, including data entry, inventory software, and Microsoft Office.
- Strong attention to detail and ability to follow instructions with minimal supervision.
Work Environment
- ISO 7 cleanroom environment.
- Controlled Non-Classified (CNC) production area.
- Requires proper gowning and adherence to GMP/cleanroom procedures.
- May involve operating multiple pieces of equipment and repetitive production activities.