Assay Verification & Validation Technician

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

At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Assay Verification and Validation (V&V) Technician to support verification and validation testing of new in vitro diagnostic products and changes to released products. This role contributes to V&V activities of complex diagnostic systems comprised of biochemical, molecular, and immunoassay-based assays, reagents, consumables, instruments, and software. This role requires a highly detail-oriented individual to execute test protocols for products transitioning out of development and to support continuous improvement of on-market products with scientific rigor, regulatory compliance and focus on data integrity.

This is an onsite position in San Diego, CA, operating on a 4x10 schedule (Monday-Thursday or Tuesday-Friday).

Note: This position is not currently eligible for visa sponsorship.

The Responsibilities

• Acquire and maintain expertise in QuidelOrtho platforms, with focus assays, reagents, consumables instruments and software.
• Partner with the V&V leadership to understand deliverables for verification and validation studies in support of product development and lifecycle changes.
• Supports product optimization, troubleshooting, and process improvement activities in collaboration with cross-functional teams.
• Draft test protocols, follow protocols meticulously and independently to execute testing, communicate results with V&V leadership and draft reports.
• Maintain clear, detailed, and well-organized laboratory notebooks and records in accordance with Good Documentation Practices (GDP).
• Participate effectively in team environments, maintain clear communication with supervisors and peers regarding study progress, results and issues.
• Always ensure compliance with all safety standards and established business policies.
• Perform other work-related duties as assigned.

The Individual

Required:

• Bachelor's degree in Biology, Molecular Biology, Biochemistry, or related discipline or equivalent combination of education and work experience.
• At least 3-4 years of laboratory experience with a strong scientific background.
• Hands-on expertise in immunoassays, molecular biology, with proven experience in PCR, RT-PCR, and related assays in a regulated or research laboratory environment
• Experience working in a biosafety hood and handling viruses, bacteria, and infectious or potentially infectious samples (BSL2 level).
• Comfortable to work with collection and handling of different sample types.
• Working knowledge of GMP and ISO 13485 quality system regulations.
• Ability and willingness to work cross-functionally and support new technology transfers in a fast-paced environment.
• Strong organizational skills with the ability to manage multiple tasks and priorities
  simultaneously.
• Excellent verbal and written communication skills.
• Demonstrates a high level of professionalism, strong initiative, and a proactive commitment to learning and continuous improvement.
• Desire to actively seek out new, job-related responsibilities and learning opportunities.
• Proficiency with standard computer applications (e-mail, Microsoft Office, Excel or
  equivalent).

Preferred:

• Experience in Verification and Validation studies for in vitro diagnostic assays or complex systems
• Expertise in writing protocols and reports
• Experience training others and participating in new technology transfers.
• Experience working in GDP/GMP or other regulated environments.

The Key Working Relationships

Internal Partners:

• Quality/Regulatory, Operations, Manufacturing and cross-functional members of the organization.

External Partners:

• Customers and vendors.

The Work Environment

The work environment includes both office and laboratory settings and involves handling viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues and samples. The position requires ability to lift to 20 lbs., and walking, standing, and sitting for long periods of time (up to 75% of the day) are routine. 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.

Physical Demands

Ability to lift to 20 lbs., and walking, standing, and sitting for long periods of time (up to 75% of the day) are routine. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus.

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 $50,000 to $60,000 and is bonus eligible. 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 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 recruiting@quidelortho.com.

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