Operator IV

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 technician Level IV, to work as part of our manufacturing team. This position is responsible for performing manufacturing procedures and executing diverse tasks in manufacturing related to Antisera 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. This position is also 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 located in Raritan, NJ. Primary work hours 7:00am to 3:30pm, M-F

The Responsibilities

• Independently execute manufacturing and support processes according to standard operating procedures

• Accurately complete documentation in batch records, logbooks, forms and other GMP documents.

• Use of ERP system for performing material transactions/moves/quantities/cycle counts.

• Knowledge of cGMP requirements to ensure adherence to compliance policies and regulations.

• Wear the appropriate PPE when working in manufacturing and other hazardous working environments.

• Understand Lean Principles as it relates to work.

•  Actively participate in team meetings

• 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.

• Quality and Regulatory Compliance including reviews and resolutions of non-conformances, audit preparation and participation and, understanding and utilization of the Quality Management systems to support production compliance.

• Demonstrate training progression through assigned curriculum

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

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

• Ability to flex work hours, or work other shifts as necessary to meet business needs while supporting the night shift operations staff

• Overtime is required, as necessary.

• Perform other work-related duties as assigned.

The Individual

Required:

• HS Diploma or Equivalent is required.

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

• Ability to demonstrate flexibility and adaptability; ability to prioritize within a changing business environment.

• Demonstrates an attention detail; ability to stay focused on the task at hand for long periods of time.

• Ability to effectively communicate; demonstrate a sense of urgency to complete production schedule on time; accepts personal responsibility for the quality and timeliness of work.

• Basic computer skills i.e. Microsoft Office (Word, Excel, Outlook)

• Ability to work both independently and within a team environment.

• Be an advocate for a safe work environment and be responsible for my safety and the safety of others.

The Key Working Relationships

• Internal – Operations, Materials Management, Quality, EHS, Facilities, Engineering, Product Support 

• External- Suppliers

The Work Environment

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.

Physical Demands

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 800 lbs. devices with wheels. PPE as required by the area. Ability to work a rotating shift schedule, overtime and weekends as needed to meet production requirements. Flexible work hours to meet project deadlines.

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 for this position is $79,000. 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 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 the 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].