Assay Verification & Validation Technician
About The Position
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.
Requirements
- 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).
Nice To Haves
- 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.
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.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
