Production Operator

Location: Irwindale, CA
Department: Azzur Solutions, LLC

Job Description

Production Operator:

Azzur Group partners with leading pharmaceutical, biotechnology, and medical device manufacturers to provide efficient and innovative solutions that help them start, scale, and sustain their GxP organizations. With experts at more than 15 locations throughout the United States, we take pride in our development and execution of phase-appropriate quality and compliance services to our clients From Discovery To Delivery TM.

Job Description:

The Production Operator (Level 1) will work closely with other production personnel and Quality personnel to perform inspection and packaging of the final product in line with company and industry standards.
 Works closely with other departments to ensure that batch production is completed in a safe, compliant, and timely manner
 Wears proper personal protective equipment in controlled areas.
 Cleans the packaging line after lot packaging completion, removes all items from previous lots prior to new lot’s packaging.
 Completes label, insert, carton counts.
 Cleaning of packaging area.
 Prepares stopper detector and label machine by performing daily checks. Completes all necessary cleaning and preventative maintenance checks and documents all associated tasks.
 Operates stopper detector and labelling machine.
 Adheres to production schedules and ensures that all tasks are performed in a timely manner.
 Completes all related bath production documentation.
 Troubleshoots basic production related issues such as packaging discrepancies, equipment problems, etc.
 Documents all activities as they occur in logbooks and Production Batch records as required. Maintains cleaning logs per SOP requirements.
 Aids management for investigations.
 Updates job knowledge by participating in training opportunities. Takes ownership for individual training plan.
 Assists with the training of new operators as required on the packaging line.
 Maintains labelling cage (i.e. label control).
 Preparing items for autoclaving, running autoclaving loads.

LEVEL 1: Inspection, Packaging, Preparation.

Education:
High school diploma GED or College Diploma in Sciences or BSc

Experience:
 0-2 years

Technical:
 Must be able to perform calculations using simple mathematical formulas using percentages.
 Good command of the English Language. Must be able to read, understand, follow and comply with technical and written documents and processing instructions as well as clearly and accurately document all required information into batch documents.
 Mechanical aptitude required in order to operate PLC and labeling machine.
 Must be able to work around chemicals such as acids, bases, oxidizers and cleaning solvents while wearing appropriate PPE.
 Manufacturing experience in a GMP environment. Pharmaceutical production experience is highly preferred.
 Autoclaving experience – such as wrapping items using autoclaving material, setting up loads for autoclave.
 Packaging experience – such as doing needed paper work for labels, inserts and boxes.
 Physical requirements include stooping, bending, standing, climbing and lifting of between 20 kg – 30kg. Must be able to work while wearing full protective gowning for entire shift.

Behavioral:
 High integrity, flexibility in working overtime, reliable, with good attention to details, good problem solving. Ability to work effectively independently and part of a team.


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