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, we are seeking a Manufacturing Operator III in the ELISA Plate production area.  This position is responsible for performing manufacturing procedures and executing diverse tasks in manufacturing related to Donor Screening ELISA Plate processing 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 located in Raritan, NJ.  Hours: 6:00am to 2:30pm Mon – Fri. Overtime and shift work is required, as necessary.

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/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 utilizing equipment such as: (ELISA plate equipment and pouches)

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.

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 in representing the area for site wide projects as required.

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

Strong mechanical and troubleshooting knowledge within area

Train other technicians on procedures.

Assist with schedule updates in coordination with team members and leadership.

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.

The Individual

Required:

HS Diploma or Equivalent

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

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.

Stand; walk; climb, bend and stoop; and reach with hands and arms for extended periods of time.

Ability to lift up to 40 lbs.

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.

The Key Working Relationships

Internal Partners:  Equipment Manufacturing Operators, Quality Engineers, Field Engineers, Customer Service, Warehouse personnel

External Partners:  Material Suppliers and Customers

The Work Environment

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

The Physical Demands

Position requires ability to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position. 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. Must pass vision acuity test for inspection of work in process and finished goods. 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.

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 $49,000 - $59,000. 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 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 recruiting@quidelortho.com.

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