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OI
Production Operator
Otsuka ICU Med · Austin, TX, United States
About The Role
Reports to: Eladio Perez
- Dept: 1274 - Irr Sterilization
- Shift: 3rd - Sunday - Thur, 9:30pm - 6:00am
Essential Duties & Responsibilities
- Performs a variety of consistent repetitive tasks and other activities as specified in standard operating procedures (SOPs).
- Responsible for achieving production standards in manual operations and/or while operating equipment.
- Responsible for following safety, quality, compliance, and company policies and practices.
- Responsible for accurate and timely documentation of work in batch records, logbooks, and other official documents.
- Perform and document lot changes, line clearances, production processes and cleaning operations.
- Inspect, identify, and communicate any inconsistencies of materials, commodities, product, process, or equipment in a timely manner
- Work in a team environment to coordinate activities, solve problems, and effectively communicate.
- Remain flexible and adaptable to change.
- Adhere to current Good Manufacturing Practices (cGMP) regulatory guidelines, and Job Safety Analysis (JSA).
- Ability to perform minor adjustments, clear jams, evaluate products within specified limits and troubleshoot equipment.
- Perform other duties as assigned or required.
Knowledge & Skills
- Must accurately follow both verbal and written instructions.
- Ability to perform and document basic mathematical calculations, (e.g. add, subtract, multiply, divide, work with fractions, decimals and percentages).
- Must be able to identify issues and solve problems.
- Must be able to work respectfully in a team environment.
- Must be able to communicate effectively.
- Must be able to pass the Good Manufacturing Practices (GMP) test and obtain required area certifications.
Minimum Qualifications, Education & Experience
- High School education or equivalent required. Two years of verifiable Manufacturing experience may be substituted for a HS diploma.
- Must be at least 18 years of age
- Ability to read, write, understand, and communicate in English.
Work Environment .
- Typically requires travel less than 5% of the time
- Varying levels of physical activity based on specific assignment including standing, sitting, stooping, lifting, and fine motor skills with hands
- Consistent, repetitive tasks while on the production line.
- Must wear hearing protection, safety shoes, Safety Glasses, prescription glasses (if prescribed), and any/all personal protective equipment (PPE) required to perform jobs in assigned areas.
- Must be comfortable wearing complete (head to toe) gowning material.
- No forms of jewelry including rings, necklaces, earrings, and any other piercings, are allowed in the production areas except a Medical Alert neck chain.
- Cosmetics, lash extensions, artificial nails, nail polish, nail enhancer, or any type of nail coating(s) cannot be worn in production areas.
- May be required to work outside and its elements, to assist with material disposition.
- Must be able to lift up to 35 lbs. unassisted and up to 75 lbs. assisted.
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