Calibration Process Specialist

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 Calibration Process Specialist position is a vital part of the calibration documentation program and compliance to regulatory standards. You will be working closely with the Engineering Metrology and Manufacturing Maintenance departments, reporting into the Manager of Manufacturing Engineering. The Process Specialist will have the responsibility of supporting the calibration documentation system for scheduled calibrations and preventative maintenance. The results of your work may be requested during an audit. This position will need familiarity with working in an FDA regulated environment and will uphold the highest integrity toward data accuracy for ISO 9001 compliance.

This Position will be located onsite in Carlsbad, CA.

• Works directly with External Calibration vendors to complete timely measuring and test equipment calibrations.

• Expedites equipment in and out of the facility for recalibration and certification.

• Updates and maintains accurate and detailed calibration records and maintenance documentation using EAM (Enterprise Asset management) preventative maintenance system.

• Communicates verbally and in writing project status updates and requests for information.

• Supports departments with new equipment forms (NEFs) to ensure asset number assignment and proper setup of new equipment in EAM.

• Develops equipment calibration schedule and provides to necessary departments for asset retrieval and calibration.

• Supports corrective and preventative actions (CAPA) when applicable to equipment calibrations or calibration processes.

• Reviews as found data from calibration system to determine if calibration intervals for equipment have been appropriately set.

• Performs duties in compliance with established business policies.

• Perform other work-related duties as assigned

Required:

• AA/AS in Life Sciences, Laboratory, Manufacturing or related equipment field or 1 to 3 years of relevant experience.

• Proficient using Microsoft technology, particularly Excel.

• This position is not currently eligible for visa sponsorship.

Preferred:

• Detail orientated with excellent documentation skills.

• Excellent organizational skills and the ability to prioritize multiple tasks.

• Excellent time management skills to achieve goals in a timely manner.

• Able to learn and follow routine procedures independently.

• Able to work collaboratively in a team environment, including inter-departmental teams.

• Knowledge of cGMP manufacturing.

• Understanding of ISO 9001.

• Able to maintain regular and reliable attendance.

Internal Partners:

Purchasing, Receiving Inspection, Quality Engineering, Manufacturing and Engineering

External Partners:

Service Contractors and Outside Vendors/Regulatory Agencies

The work environment characteristics are representative of both an office and laboratory environment. Some time spent in production areas and warehouse.Flexible work hours to meetproduct demanddeadlines.

Position requires ability to lift up to 30 lbs. on occasion. Up to 75% of time at the desk on computer/doing paperwork/ on phone, doing analytical work (10% of time in meetings). Walking, standing, and sitting for extended periods of time are routine to accomplish tasks in this role. Position may require use of Personal Protective Equipment as posted.

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 $44,000 to $57,000 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.

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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