Production Operator

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 21,000 - 28,000; Full time

Job summary

Otsuka ICU Medical LLC is seeking a production associate to perform production line and material handling tasks in manufacturing. You will help achieve standard production rates while following safety, compliance, and company policies, and document work in batch records and logbooks.

You will inspect components and final products, perform lot changes and line clearances, and collaborate with a team to improve quality, cost, and safety.

Qualifications

• High school education or equivalent is required.
• Must be at least 18 years of age.

Responsibilities

• Inspect components, materials, documents and final products either as inherent part of the production process or offline.
• Perform lot changes, line clearances, production processes and cleaning operations.
• Identify non-conforming product (rejects).
• Achieve established labor standards for the respective tasks.
• Provide information on commodity and process issues. Ensures quality products are delivered to subsequent processes.
• Adhere to cGMP guidelines and SOPs.

Skills

English proficiency

Follow instructions

Basic math

Mechanical adjustments

GMP certification

Education

High School diploma

Job description

Position Summary

Performs any one or combination of production line and material handling in manufacturing. Responsible for achieving production standards in manual operations and/or while operating equipment requiring average mechanical skills and aptitude. Responsible for achieving standard production rates, following safety, compliance, and company policies and practices. Responsible for accurate and timely documentation of work in batch records, logbooks and other official documents.

• Inspect components, materials, documents and final products either as inherent part of the production process or offline. Performs activities specified in batch record and SOP's. Sample and evaluate product per defined methods, recognizes action levels and notifies area specialist and supervisor if out of limits.
• Perform and document lot changes, line clearances, production processes and cleaning operations.
• Achieve established labor standards for the respective tasks.
• Provide information and feedback on commodity and process issues. Ensures quality products are delivered to subsequent processes.
• Work in a team environment to coordinate activities, solve problems and effectively communicate. Adapt to changes in a constructive manner. Participation in area improvements, cost reductions, and meetings. Provide information and feedback on commodity and process issues. Ensures quality products are delivered to subsequent processes.
• Adhere to cGMP guidelines, SOP's and plant policies/rules.
• All other duties as deemed necessary by supervisor or manager.
• Able to evaluate process, product and equipment performance based on prescribed procedures.
• Work with team members to reach consensus to optimize quality, cost, compliance, customer service and safety.
• Perform other related duties as assigned or required, to include working in the outside elements for material disposition.

Job Description

Performs any one or combination of production line and material handling in manufacturing. Responsible for achieving production standards in manual operations and/or while operating equipment requiring average mechanical skills and aptitude. Responsible for achieving standard production rates, following safety, compliance, and company policies and practices. Responsible for accurate and timely documentation of work in batch records, logbooks and other official documents.

Essential Duties & Responsibilities

• Inspect components, materials, documents and final products either as inherent part of the production process or offline. Performs activities specified in batch record and SOP's. Sample and evaluate product per defined methods, recognizes action levels and notifies area specialist and supervisor if out of limits.
• Perform and document lot changes, line clearances, production processes and cleaning operations.
• Identify non-conforming product (rejects).
• Achieve established labor standards for the respective tasks.
• Provide information and feedback on commodity and process issues. Ensures quality products are delivered to subsequent processes.
• Work in a team environment to coordinate activities, solve problems and effectively communicate. Adapt to changes in a constructive manner. Participation in area improvements, cost reductions, and meetings. Provide information and feedback on commodity and process issues. Ensures quality products are delivered to subsequent processes.
• Adhere to cGMP guidelines, SOP's and plant policies/rules.
• All other duties as deemed necessary by supervisor or manager.
• Able to evaluate process, product and equipment performance based on prescribed procedures.
• Work with team members to reach consensus to optimize quality, cost, compliance, customer service and safety.
• Perform other related duties as assigned or required, to include working in the outside elements for material disposition.

Knowledge & Skills

• Ability to read, write, understand and communicate in English.
• 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).
• Ability to perform minor mechanical adjustments, clear jams, evaluate product within specified limits and troubleshoot equipment.
• Must be able to pass the GMP test and obtain area certifications.

Minimum Qualifications, Education & Experience

• High School education or equivalent required.
• Must be at least 18 years of age

Work Environment

• Typically requires travel less than 5% of the time
• This position is required to ensure production standards are met.
• Varying levels of physical activity based on specific assignment.
• Must wear hearing protection, safety shoes, prescription glasses (if prescribed), and any/all personal protective equipment (PPE) required to perform jobs in assigned 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.

About Us

Innovation, Impact, and Purpose.

Find Your Future Here.

We manufacture the critical IV solutions providers count on to deliver consistent, reliable care. Each product we make helps ensure patients receive the therapies they need without disruption.

When you work here, you become part of something bigger—a team dedicated to reliability and innovation. No matter the role, your work directly strengthens the healthcare supply chain and impacts patients nationwide.

We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters.

Join us and help shape the future of IV solutions.

EEO Statement

Otsuka ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at [e-mail]. We are committed to providing equal access and opportunities for all candidates.

Otsuka ICU Medical EEO Policy Statement

Know Your Rights: Workplace Discrimination is Illegal Poster

Otsuka ICU Medical CCPA Notice to Job Applicants