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

The Technician IV, Instrument Calibration will be responsible for duties include performance and documentation of routine calibrations and preventive maintenance tasks on the following instruments: Temperature, humidity and pressure measuring devices as well as sterilization equipment, stability chambers, analytical equipment, environmental monitoring systems. Proper execution of calibration procedures, system training, and timely attainment of instrument calibrations. Responsible for the calibration, preventative maintenance, troubleshooting and repairs of a variety of manufacturing, facility, and utility instruments. This role will also be responsible for some activities involving working in a clean room environment as well as (DI/RO) Process Water Systems. Candidate must coordinate responsibilities with both the cGMP Maintenance Planners and Facilities to ensure overall equipment effectiveness. Coordination and guidance to external vendors and suppliers as it relates to following written procedures as well as performing various activities and support functions. Authoring and executing validation protocols as it pertains to: temperature, humidity devices, pressure measuring devices, sterilization equipment, stability chambers, analytical equipment and environmental monitoring systems.

The position will require some off hours based on business needs

This is a first shift position and will be located in Raritan, NJ.  

The Responsibilities

Manage the calibration workload through the use of ProCal V software .  Execute all calibrations to meet daily, weekly, annual production. Maintain records through proper documentation in the ProCal V system of record. Identify any issues and address them through in a cGMP compliant manner.  Maintain an open line of communication with customer base. Participates and collaborates with contracted support, Manufacturing, Facilities, Quality, Product Support and Engineering.

Identify Nonconformances (NC’s) and work with our customers and Quality to ensure timely closure

Participate in departmental goals and objectives. Review documentation of training for completeness and content and promote cGMPs, proper safety practices, and proper environmental practices. Makes hiring and termination decisions. Complete performance appraisals of manufacturing team.

Provides direction on projects including new and improved products and processes while meeting established timelines.  Reviews and approves validation protocols and reports.

Coordinate and oversee contracted support during shutdowns or area projects

Proper execution of calibration procedures, system training, and timely attainment of instrument calibrations.

Responsible for the calibration, preventative maintenance, troubleshooting and repairs of a variety of manufacturing, facility, and utility instruments.

This role will also be responsible for some activities involving working in a clean room environment as well as (DI/RO) Process Water Systems. Candidate must coordinate responsibilities with both the cGMP Maintenance Planners and Facilities to ensure overall equipment effectiveness.

Coordination and guidance to external vendors and suppliers as it relates to following written procedures as well as performing various activities and support functions.

Assist in executing validation protocols as it pertains to: temperature, humidity devices, pressure measuring devices, sterilization equipment, stability chambers, analytical equipment and environmental monitoring systems. 

Perform other work- related duties as assigned

The Individual

Required:

Minimum of 2 year technical degree or equivalent training are preferred

Minimum of three to five years' experience performing facility and manufacturing equipment maintenance preferred, troubleshooting and repairs in a cGMP environment

Knowledge of Calibration Equipment ie: (Multimeter, Calibrator, pressure and temperature and conductivity standards. Calibration CMMS (ProCal IV) , non-conformance reporting, cGMP’s)

Excellent computer skills, including Microsoft Office

Ability to demonstrate effective oral and written communication skills

Ability to prioritize, lead and/or support multiple tasks

Ability to demonstrate mechanical aptitude

Preferred:

Associate Degree in Electronics or equivalent calibration certification. A 2-year technical degree in Electronics or equivalent training

Key Working Relationships 

Internal: Manufacturing, Quality, EHS, Facilities, Engineering, and Product Support.

External: Suppliers

The Work Environment

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

The Physical Demands

Some lifting required, not to exceed 50 pounds. Manual dexterity required for handling of precision instruments. Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position. Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.  Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position. Is frequently required to communicate with coworkers. 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. Work with blood, blood products and chemicals. Must pass vision acuity test for inspection of  work in process and finished goods. Overtime is required, as necessary. Ability to occasionally work other Shifts 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 $57,000 - $77,000 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 recruiting@quidelortho.com.

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