Assay Verification and Validation Technician

Ortho-Clinical Diagnostics

San Diego, CA

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 an Assay Verification and Validation (V&V) Technician to be responsible for verification and validation testing of new products and changes to released products. The Assay V&V Technician contributes to verification and validation activities for multiple systems comprised of assays, reagents, consumables, instruments, and software. The role requires a strong detail-focused skill set to execute tests of products exiting development and to further support and improve products within manufacturing.

This is an onsite position in San Diego, CA.

The Responsibilities
  • Acquires and maintains expertise in the use and testing of the multiple platforms within Quidel, with a focus on assays, reagents, and consumables.

  • Works with V&V Manager and V&V Lead to execute V&V studies.

  • Executes ad-hoc testing to support pre-V&V activities.

  • Executes testing protocols and generates reports.

  • Supports product improvement and manufacturing optimization.

  • Executes experiments and validation protocols, supports problem-solving and trouble-shooting activities with guidance from Team Lead & Manager.

  • Maintains detailed and organized notebooks and records.

  • Participates in team environments and interacts with team members professionally; trains others as needed.

  • Maintains good communication with supervisor and peers.

  • Maintains safe working environment.

  • Carries out duties in compliance with established business policies.

  • Performs other responsibilities as assigned.

The Individual

Required Skills:

  • Bachelor’s degree in Biology, Chemistry, Molecular Biology, Biochemistry, or related discipline.

  • At least 1-2 years laboratory or equivalent experience.

  • Knowledge of design control.

  • Background in chemistry, biochemistry, molecular biology, virology, immunology, or related field.

  • Knowledge of assay development, process development, problem solving and statistical experimental design.

  • Able to train others and participate/coordinate new technology transfers.

  • Excellent organizational skills and an ability to perform multiple tasks simultaneously.

  • Excellent communication skills (verbal and written).

  • Must exhibit professionalism and maturity and display desire to succeed, be motivated and proactive.

  • Working knowledge of analytical tools used in Chemistry, Biochemistry, or Immunoassay Development.

  • Working knowledge of GMP and ISO 13485 quality system regulations.

  • Demonstrate willingness and ability to work cross-functionally in other areas.

  • Desire to actively seek out new, job-related responsibilities and learning opportunities.

  • Appropriate computer skills (e-mail, graphing software, word processing).

Preferred Skills:

  • Experience with design control, complex systems, and assays.

  • Experience in GDP/GMP.

The Work Environment

The work environment characteristics are representative of both an office and laboratory environment and include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues and samples. Position requires ability to lift up to 20 lbs. on a regular basis. Walking, standing, and sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Personal protective equipment is required as posted.

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 $35,700 to $66,000. 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 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