Job Description

Shift Time:

6:00 PM – 6:00 AM or 6:00 AM – 6:00 PM

Shift Structure:

24/7 schedule (3 work shifts, 2 off shifts, 2 work shifts, 3 off shifts).

12-hour shifts: 6:00 PM – 6:00 AM or 6:00 AM – 6:00 PM.

Shift structure may vary depending on business needs.

Shifts start at 5:45 PM / 5:45 AM , gowned up and ready for the shift meeting.

Summary:

Supports the manufacturing processes relative to the department/area in which they are assigned. Operate manufacturing equipment based on the established written procedures and work rules. Responsible for product quality and safety on the assigned line and for achieving production standards in both quantity and quality. Understand and follow cGMP and safety guidelines as required. Follow all safety policies and procedures. Perform light cleaning in order to maintain a clean operating environment. Write maintenance summaries of assembly and workstation areas as needed. Execute quality checks in accordance to department/area requirements and document findings. Stocking, sweeping, mopping, and trash removal may be included. It is critical to be on time and available for each scheduled shift.

Responsibilities:

• Adhere to Safety and Quality policies and procedures on the assigned lines.
• Responsible for maintaining a safe work environment and working safely.
• Ability to wear safety equipment (safety glasses, safety shoes, protective gloves, safety cap, etc.).
• Proactively contribute to clear communication; good verbal and written communication skills are required.
• Proactively pursue, build, and protect an inclusive, safe, and pleasant work environment. Teamwork and respect for people are required.
• Adhere to standard operating procedures and current Good Manufacturing Practices to ensure quality and quantity of product.
• Document process steps on appropriate batch documentation.
• Attain and maintain qualification for the operation of assigned process equipment and duties in the area.
• Support the manufacturing processes relative to the department/area in which the operator is assigned.
• Operate manufacturing equipment based on the established written procedures and work rules.
• Setup and operations of equipment.
• Cleaning in order to maintain a clean operating environment (stocking, sweeping, mopping, and trash removal).
• Unpack/pack and load/unload components and product on the lines.
• Execute quality checks in accordance to department/area requirements and document findings.
• Ability to demonstrate attention to detail.
• Basic math skills and basic computer skills, with the capability to learn in more detail.
• Documentation skills.
• This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.
• It is critical to be on time and available for each scheduled shift.
• Ability to work overtime, weekends, and off shifts.
• Shifts structure 24/7 schedule (3 work shifts, 2 off shifts, 2 work shifts, 3 off shifts). 12-hour shifts. 6:00 PM / 6:00 AM. Shift structure may vary depending on business needs.
• Shifts start at 5:45 PM / 5:45 AM, gowned up and ready for the shift meeting.

Qualifications:

• Must have at least 5 years of Manufacturing experience.
• Experience with GMP environment, strong ability to multitask, technical abilities, and troubleshooting.

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