Job Purpose

The Manufacturing Associate I applies direct labor for manufacturing high-quality diagnostic products using manual and semi-automated equipment. This role is responsible for setting up, calibrating, and operating all manufacturing equipment in line with cGMP, POPs, SOPs, Safety, and departmental policies. You will use good judgment and critical thinking skills to make operator-level decisions regarding product quality.

Key Responsibilities

• Prepare products according to approved Manufacturing Process Operating Procedures (POP’s), Standard Operating Procedures (SOP’s), cGMP, and ISO 13485 quality systems.
• Perform all assigned manufacturing processes while adhering strictly to departmental safety policies to ensure minimal error.
• Maintain work area in a clean and orderly fashion, promoting a positive teamwork environment and continuously sharing improvement ideas.
• Support other departments as needed to facilitate cross-training and assist the business unit.
• Occasionally be required to lift and move materials weighing up to 50 lbs using appropriate equipment.
• This role may include other tasks not specifically outlined in this position description as directed by the manager.

Work Environment

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Operate in biological and chemical manufacturing environments.
• Cleanroom environment.
• Weekend and off-hour work to accommodate operations schedule, as needed.