APR 1st Shift - Suite Operator

Work Schedule

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.)

Job Description

Responsible to produce quality culture media according to established regulations (QSR), current Good Manufacturing Practices (cGMP), and company policies and procedures.

Key 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 (SOP’s, DHR’s, 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.

In addition, other duties may be assigned as the business needs warrant.

Minimum Requirements/Qualifications

· 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 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.

· Possess basic mechanical aptitude.

· Possess basic computer skills.

Non-Negotiable Hiring Criteria

• ·Must have High School Diploma or equivalent.
• 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 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.