Operator, Fill​/Label​/Pack; B Shift

The Opportunity

Quidel Ortho 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.

We are seeking an 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.

Work Schedule: B Shift - Monday through Friday, 2:00 p.m. to 10:30 p.m., with occasional weekend work as needed.

• 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
• Perform other duties as assigned

Required:

• High School Diploma, GED.
• 2-4 years of experience in MD&D, pharmaceutical, or related manufacturing.
• Basic computer skills, including MS Office, and accurate ERP data entry.
• Strong mechanical aptitude, troubleshooting, and problem-solving skills.
• Ability to read, write, and communicate effectively in English.
• Familiarity with manufacturing processes, systems, SOPs, batch records, and safety procedures.
• Proficiency in basic math and understanding of Lean principles and value stream mapping.

Preferred:

• 1-2 years of experience within operations/manufacturing environment.. Relatable experience may be considered.

Internal Partners:
Maintenance, Engineering, Quality, Warehouse

External Partners:
Suppliers

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time you will be, standing, walking or sitting for extended periods of time. Ability to lift up to 50 lbs.,

frequent lifting of 21-30 lbs., and use force to pull or push up to…