Job Description

Position Overview:

The Operator – Visual Inspection will work at our client's Manufacturing site in Kenosha County WI, where parenteral products for domestic and international markets are manufactured and packaged. The primary purpose of this role is to safely inspect high-quality pharmaceutical products in accordance with site standards and current Good Manufacturing Practices (cGMP) within controlled facilities.

This position requires operation of various automated and semi-automated manufacturing equipment, as well as performance of manual inspections. The operator is responsible for ensuring product quality while demonstrating a strong commitment to safety, compliance, and operational excellence.

Responsibilities:

• Adhere to Parenteral Manufacturing safety policies and procedures and contribute to a safe work environment.

• Set up and operate non-aseptic manufacturing processes, including automated and semi-automated inspection equipment in controlled facilities.

• Follow standard operating procedures (SOPs), cGMP requirements, and safety policies and procedures.

• Accurately document process steps using appropriate batch documentation systems (paper and electronic).

• Participate in department meetings, team-building activities, and training programs.

• Provide input into department SOPs and training materials as needed.

• Maintain accountability for working safely and supporting all site and corporate health and safety goals.

Basic Requirements:

• Minimum education: High School Diploma or GED

• Must pass a post-offer physical examination

• Must pass an eye exam and not be color blind

• Ability to wear required safety equipment (safety glasses, safety shoes, protective gloves, etc.)

• Ability to work within a shift-based schedule

• Willingness to work overtime, weekends, and off-shifts as required

Additional Skills / Preferences:

• Experience working in a GMP-regulated environment

• Ability to troubleshoot basic production issues and effectively use tools

• Experience with PMX, MasterControl, Flow-stream, or other electronic batch documentation systems

• Previous pharmaceutical manufacturing experience

• Experience with manual, automated, and semi-automated inspection processes

• Strong attention to detail when performing manufacturing tasks and documenting production activities on paper and computer-based systems

• Basic math skills, including evaluation and interpretation of production data

• Basic computer skills, including use of HMIs and other computer terminals to monitor equipment status and document production activities

• Excellent documentation skills

• Proven teamwork skills and ability to work closely with operations teams during line setup, operation, and changeovers

Additional Information:

• Ability to work overtime as required

• Ability to wear required safety equipment (glasses, shoes, gloves, etc.)

• Primary work location: Kenosha County, Wisconsin

• Ability to travel up to approximately 10%

This job description is intended to provide a general overview of the job requirements at the time it was prepared. Job responsibilities may change over time and may include additional duties not specifically described. For GMP purposes, the job description should be updated for significant changes. Employees should consult their supervisor regarding actual job responsibilities and related duties.

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