Manufacturing Operator Ii, Fill Label, Pack

4 days ago

Pompano Beach, United States QuidelOrtho Full time

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Opportunity

As we continue to grow, we are seeking a Manufacturing Operator II in the manufacturing/production department. This position is responsible for performing manufacturing procedures and executing diverse tasks in various manufacturing areas related to Filling, Labeling, Packaging and Line Tending according to detailed operational specifications and execution of scheduled tasks within a cGMP environment. While ensuring materials are available to meet production schedule, this position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures and all applicable regulations. Accountable for adhering to all EHS guidelines. This position is located in Pompano Beach, Florida.

This is a 3rd shift position. 10:00pm to 6:30am

The Responsibilities- Execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum.- Support schedule adjustments to meet production, material receipt and shipping requirements.- Work with Shift Leader//Team Leader to review departmental production schedules, work orders and related information to ensure materials are available for production.- Maintain working knowledge of cGMP requirements to ensure adherence to compliance policies and regulations- Sets up and operates production equipment to produce work in process and finished goods- Perform in-process testing as required by processes and procedures utilizing equipment such as: (Fill, Label, Pack equipment, testers, scales and printers) list is not all inclusive- Check products online to confirm proper assembly and remove defective products- Take samples for further downstream testing and perform tests during processing according to standard procedures- Use of ERP system for performing material transactions/moves/quantities/cycle counts- Cleans, maintains, and performs basic repairs on equipment as needed- Operate and troubleshoot equipment in clean room and non-clean room environment- Assure manufacturing facility and equipment meets all requirements prior to production on all shifts.- Accurately complete documentation in batch records, logbooks, forms and other GMP documents.- Verify and enter production parameters per SOP and Batch Records.- Monitor environmental conditions inside and outside classified rooms- Wear the appropriate PPE when working in manufacturing and other working environments.- Demonstrate training progression, train designated personnel in all levels of responsibility- Understand Lean principles as it relates to work- Understand Value Stream maps and relevancy- Actively participates in Kaizen, problem solving and asset care- Proactively maintain a clean and safe work environment by performing sanitizing and housekeeping duties and looks for opportunities to improve. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors

The Individual- Minimum of 2-4 Years MD&D/Pharmaceutical experience or equivalent industry experience- High School diploma required- Good mechanical and troubleshooting knowledge within functional area.- Demonstrate a good understanding of the process in order to properly perform the assigned manufacturing tasks.- Good working knowledge and understanding of systems as required.- Utilizes tools within MS Office and other systems to improve business effectiveness.- Accurate Data Entry skills in ERP system.- Read and interpret documents such as safety rules, operating instructions and logbooks.- Review and provide feedback for SOP and Batch Record Revisions.- Good communication and written skills.- Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals.- Understand Lean principles as it relates to work.- Understand Value Stream maps and relevancy.- Actively participates in Kaizen, problem solving and asset care
- Physical Demands:_- While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; climb, bend and stoop; and reach with hands and arms for extended periods of time.- Must pass vision acuity tes

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