Validation Specialist

1 week ago


Santa Clarita, California, United States IQVIA Full time
Validation Scientist Job Description

We are seeking a skilled Validation Scientist to join our team at Q2 Solutions, IQVIA's laboratory business in Valencia, CA.

As a Validation Scientist, you will be responsible for performing technical procedures and experimental execution in support of sample analysis for Anatomic Pathology validations. You will also be involved in validation planning, reagent ordering, SOP writing, and validation report writing.

Key Responsibilities:
  • Perform and document analytical procedures in accordance with company procedures and regulatory guidelines.
  • Assist in troubleshooting and process improvements to increase data quality, lower costs, or reduce turnaround times.
  • Act as a technical resource for laboratory staff and support the team in the absence of the line manager.
  • Perform routine data analysis to determine if an analytical procedure is proceeding according to expectations and that the results are within acceptable tolerances.
  • Identify and document potential performance errors or otherwise unusual results and escalate to senior lab personnel.
Requirements:
  • Bachelor's Degree or equivalent combination of education and experience. Some CAP/CLIA lab locations may require a BSc in a chemical, physical, biological or clinical laboratory science, medical laboratory technology or cytotechnology.
  • Typically requires more than 2 years of experience.
  • Minimum 1 year of experience in a regulated laboratory environment preferred.
  • Sound knowledge of principles, theories, and concepts in job area.
Knowledge, Skills and Abilities:
  • Working knowledge of any applicable regulatory standards within area of responsibility.
  • Proficiency with relevant laboratory techniques.
  • Knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling.
  • 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.
What We Offer:

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 our website.

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

Q2 Solutions, IQVIA's laboratory business, creates connected intelligence by combining our expertise, technology and analytics - this fuels unparalleled research & development solutions. We uphold a deep commitment to patients, sites, customers, and each other.

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

Q2 Solutions' ability to operate and provide certain services to customers and partners necessitates Q2 Solutions and its employees meet specific requirements regarding COVID-19 vaccination status.



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