Manufacturing Operator III

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.

As we continue to grow as one QuidelOrtho we are seeking an Operator III to work in our manufacturing facility in Raritan, NJ. The Operator III is responsible for performing manufacturing procedures and executing diverse tasks in manufacturing related to Bovine Serum production according to detailed operational specifications and execution of scheduled tasks within a cGMP environment. Ensure materials are available to meet production schedule. This position is responsible for maintaining the highest standards in compliance and quality within company policies, procedures and all applicable regulations. Accountable for adhering to all EHS guidelines.

This position is in Raritan, NJ.

• 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/Supervisor 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.

• 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.

• 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.

• Independently performs manufacturing daily tasks and understands the inter-relationship of upstream and downstream activities.

• Perform validation activities within the area in partnership with team members.

• Assists and may lead troubleshooting of routine manufacturing equipment and processes.

The Individual

Required:

• HS Diploma or Equivalent required.

• Minimum of 4-6 Years MD&D/Pharmaceutical experience or equivalent industry experience.

• Strong mechanical and troubleshooting knowledge within area.

• Train other technicians on procedures.

• Assist with schedule updates in coordination with team members and management.

• Demonstrate a strong understanding of the process in order to properly perform the assigned manufacturing tasks.

• Identify and assist in resolving discrepancies or trends that might need additional attention and follows up with supervision.

• Strong 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.

Internal: Strong working relationship with the site's Material Management, Quality, Upstream Formulations, EHS, Facilities, Engineering, Product Support are necessary to drive effective prioritization and collaboration to meet the needs of the business.

External: Suppliers

The work environment characteristics are representative of an office environment. Up to 75% of time at desk, standing or sitting extended periods of time. No strenuous physical activity, though occasional light lifting of files and related materials (up to 10 lbs.) is required. Will require domestic and international travel up to 20%. Ability to travel on short notice.

• Frequently required to communicate with coworkers.

• While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend and stoop; and reach with hands and arms for extended periods of time.

• Ability to lift up to 40 lbs.

• Needs to perform gowning procedures to work in manufacturing core or classified rooms.

• Work with blood, blood products and chemicals.

• Work in a cGMP area and/or clean room environment.

• Overtime is required, as necessary.

• Shift work may be required, as necessary.

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.

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