We are seeking a Laboratory Technical Specialist to join Q2 Solutions, IQVIA’s laboratory business at Valencia, CA

We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us as we transform and accelerate research and development.

You will lead the production and development of specialized reagents for digital ELISA assays, collaborating cross-functionally to drive product transfer and support diagnostic assay manufacturing. This is a fully on-site position.

What You’ll Be Doing:

Develops and maintains the local laboratory Quality Control Program and database, performs statistical analysis of data and quality control performance data reviews in accordance with policy and regulatory guidelines.

Validate assays through statistical analysis of local laboratory data, troubleshooting the effective implementation of analytical methods and the provision of technical information to relevant parties.

Develops and maintains all aspects and phases of proficiency testing and accreditation programs for the local laboratory, including but not limited to enrollment, submission/review and investigations.

Develops and maintains the yearly schedules for regulatory functions and performs data analysis for performing linearity and comparison studies, or other studies as required by various agencies and/or as requested by sponsors.

Acts as technical SME to liase with IT/systems teams to ensure appropriate functionality.

Drafts new standard operating procedures (SOPs) and the maintenance of existing SOPs related to the departmental activities on both a regional or global basis.

Assists in process improvements and troubleshooting to improve efficiencies and quality delivery.

Supports the Technical Services team in audits/inspections from regulatory agencies and pharmaceutical sponsors.

Provides input and reviews local laboratory requirements for new studies, responds to technical inquiries and provides technical documents and data either directly or by maintaining study specific databases.

May lead projects and assist with implementation.

Supports safety and 6S requirements and initiatives.

Participates in continuing education through self-study, attending training sessions and meetings.

What We Are Looking For:

Bachelor's Degree in life sciences or other relevant field Req

1 year of experience in a clinical, research, academic or commercial/production laboratory environment.

Knowledge of relevant regulatory agency standards.

Knowledge of laboratory equipment, clinical laboratory assays, quality control and validation procedures.

Strong technical knowledge of complex testing procedures and science supporting the analysis.

Proficiency with complex laboratory calculations including averages, means, standard deviations, and various quality control metrics.

Good computer skills including proficiency with Microsoft Excel, PowerPoint and Word.

Effective organizational and interpersonal skills.

Effective communication and presentation skills.

Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Applicable certifications and licenses as required by local regulations.

Other Equivalent combination of education, training, and experience may be accepted in lieu of degree

The Knowledge, Skills and Abilities Needed for This Role:

Ability to lift up to 50 lbs, frequent standing and walking, occasional sitting, close eye work requirement (computer, typing, reading small prints). Physical demands vary depending on assigned work area and work tasks. Occasional exposure to cold temperatures.

Expertise in protein chemistry, reagent formulation, and ELISA-based platforms

Skilled in scientific documentation, technical writing, database creation, and data analysis

Proven capability to lead cross-functional projects and navigate challenging environments

What We Offer You:

We put our employees at the center of everything we do and are committed to providing them, and their families, with benefits that meet their diverse and changing needs.  We invest in integrated benefits programs and resources to take care of our employees’ physical, mental and emotional, financial and social well-being so they can thrive at home and at work, at any stage of their well-being journey.

To learn more about our benefits, visit https://jobs.iqvia.com/benefits.

If you’re looking to unleash your potential, join Q2 Solutions, IQVIA’s laboratory business, to help make the extraordinary possible!

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

The potential base pay range for this role, when annualized, is $46,200.00 - $96,200.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.