APR 1st Shift - Suite Operator

First shift (days).

Environmental Conditions

• Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair, etc. allowed
• Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.)

Responsibilities

Safety

• Perform all activities in a safe manner
• Maintain a safe, clean, and clutter-free work area
• Maintain good personal hygiene and adhere to dress code
• Listen to, follow, and relay written and verbal instructions in English
• Report safety incidents, safety hazards, and/or property damage immediately
• Wear Personal Protective Equipment (PPE) as required (safety glasses, gloves, face mask, safety shoes, etc.)
• Reference job-specific Job Safety Analysis (JSA)

Quality

• Comply with all company personnel policies
• Follow all written procedures in SOPs, DHRs, etc.
• Report discrepancies in procedures (SOPs, DHRs, etc.) to the Supervisor
• Read, understand, and complete required documentation adhering to Good Documentation Practices (GDP)
• Complete all paperwork in accordance with established policies and procedures
• Identify and utilize correct batch materials by referring to Bill of Materials (BOM)
• Inspect processes and products for quality defects
• Escalate process or product quality issues
• Don sterile gowning (hood, coveralls, gloves, mask, booties, hairnet, beard net, etc.) during operation in cleanroom environments and other aseptic processes per SOP
• Pass and maintain gowning qualification
• Perform pH measurements as needed
• Collect personal and environmental monitoring samples as required

Productivity

• Arrive to work on time and work during scheduled hours, working additional overtime as needed
• Perform basic maintenance functions and perform adjustments as required
• Escalate malfunctioning equipment immediately
• Perform and maintain aseptic processes including dispensing, inspecting, and packaging
• Set up and adjust machine to run a variety of sizes and types using tools to adjust machine
• Measure and document in-process measurements as required (weight, time, pH, etc.)
• Package product according to DHR
• Work cooperatively and efficiently with coworkers in all departments with little supervision to achieve team, department, and company goals
• Train coworkers as needed
• Obtain correct materials for operation needs from warehouse or staging area
• Assist with inventory process as required (KANBAN ordering, inventory counts, etc.)
• Complete production batches in a timely manner by following department schedules
• Reference production schedule to organize production batches, ensure materials are available, estimate timing of line batches, and schedule breaks
• Other duties may be assigned as the business needs warrant

Requirements

• High School Diploma or equivalent (non-negotiable)
• Must be able to communicate and comprehend, both written and verbally, using the English language
• Must be able to perform basic math
• Must be able to lift up to 50 lbs. and push/pull up to 600 lbs. wheeled kettles
• Stand for sustained periods of time, approximately 12 hours a day
• Ability to see and distinguish colors and work with blood
• Possess basic mechanical aptitude
• Possess basic computer skills