Production Operator

Otsuka ICU Medical•Austin, TX

11h•Onsite

About The Position

The Production Operator performs any one or combination of production line and material handling in manufacturing. This role is responsible for achieving production standards in manual operations and/or while operating equipment requiring average mechanical skills and aptitude. Key responsibilities include maintaining standard production rates, adhering to safety, compliance, and company policies, and ensuring accurate and timely documentation in batch records, logbooks, and other official documents. The company manufactures critical IV solutions, and this role contributes to strengthening the healthcare supply chain and impacting patients nationwide. It offers opportunities for growth, collaboration, and meaningful contributions towards shaping the future of IV solutions.

Requirements

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.
High School education or equivalent 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. 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.