Operator 2

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 Role

As we continue to grow as QuidelOrtho, we are seeking a Manufacturing Operator III. This position is responsible for performing manufacturing procedures and executing diverse tasks in various manufacturing areas related to Filling according to detailed operational specifications and execution of scheduled tasks within a cGMP environment. Responsible for prioritizing production requirements and coordinating the flow of materials to meet production schedules. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations. 

This is a second shift position. The hours will be from 3:00PM to 11:30PM Monday thru Friday. Training will take place on first shift for a period of 4-6 months before transferring to second shift.

This Position is located onsite at our Raritan, NJ office.

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

• Take samples for further downstream testing and perform tests during processing according to standard procedures

• 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.

• 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

• HS Diploma or Equivalent

• Utilizes tools within MS Office and other systems to improve business effectiveness

• Accurate Data Entry skills in ERP system

The Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. Is frequently required to communicate with coworkers. Work in a cGMP area and/or clean room environment. Overtime is required, as necessary. Ability to occasionally work other shifts may be required, as necessary

The Physical Demands:

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. Work with blood, blood products and chemicals.

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $42,000.00 - $71,000.00 annually. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

Equal Employment Opportunity

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 [email protected].

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