Operator II

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 the company continues to grow, we are seeking an Operator II in the Red Cell Production area. This position is responsible for performing manufacturing procedures and executing diverse tasks, manufacturing of red cell bulks according to detailed operational specifications and execution of scheduled tasks within a CGMP environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures and all applicable regulations. This position is located in Raritan, New Jersey.

Schedule: 7:00am to 3:30pm M-F.  Overtime and shift work is required, as needed.

The Responsibilities

• Perform and understand detailed processes of red cell bulk manufacturing

• Perform  in-process testing as required by processes and procedures utilizing instrumentation, such as: spectrophotometers, COBE cell washers. List is not all inclusive

• Working knowledge and understanding of test methods

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

• Assure manufacturing facility and equipment meets all requirements prior to production.

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

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

• Understand Lean Principles as it relates to work. 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 (1) audit preparation and participation and (2) understanding and utilization of the Quality Management systems to support production compliance.

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

• Demonstrate training progression through assigned curriculum

• Needs to be mobile and able to independently transport themselves between various sites/locations.  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.  Ability to lift up to 40 lbs on occasion.

• Ability to multi-task and work in a fast-paced environment.

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

• Needs to perform gowning procedures to work in cGPM and clean rooms and to work with blood, blood products and chemicals.

• Mechanical aptitude and competence.

• 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

The Individual

Required:

• Associates degree required or higher equivalent preferred

• Minimum of 2 - 4 Years MD&D/Pharmaceutical experience or equivalent regulated industry experience required.

• Creative thinker who can troubleshoot issues and think outside of the box to achieve project goals

• Demonstrated ability to collaborate and work effectively within varying degrees of ambiguity in a fast-paced environment.

Key Working Relationships

• Internal Partners:  Planning, QA, QC Inspection, Quality Engineering, Warehouse personnel, Manufacturing and Facilities

• External Partners:  Material Suppliers and Customers

The Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. 

Physical Requirements

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.  Is frequently required to communicate with coworkers.  Ability to lift-up to 40lbs.  Work with blood, blood products and chemicals.  Overtime is required, as necessary.  Shift work may be required, as necessary.  Periodic exposure to 2-8°C temperature controlled cold box during product transfer.

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 $21.63 to $26.44 hourly. 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 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].