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Validation Specialist

2 months ago


Santa Clarita, California, United States IQVIA Full time
Validation Scientist Role

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

This role involves performing technical procedures and experimental execution in support of sample analysis for Anatomic Pathology validations. The successful candidate will be responsible for validation planning, reagent ordering, SOP writing, and validation report writing.

Key Responsibilities:
  • Executing analytical procedures in accordance with company procedures and regulatory guidelines.
  • Assisting in troubleshooting and process improvements to increase data quality, lower costs, or reduce turnaround times.
  • Providing technical support to laboratory staff and acting as a resource in the absence of the line manager.
  • Performing routine data analysis to determine if an analytical procedure is proceeding according to expectations and that the results are within acceptable tolerances.
  • Identifying and documenting potential performance errors or unusual results and escalating 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 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 prioritize our employees' well-being and offer integrated benefits programs and resources to support their physical, mental, and emotional, financial, and social needs. To learn more about our benefits, visit our website.

At Q2 Solutions, IQVIA's laboratory business, we foster a culture of collaboration and innovation, empowering our employees to make a meaningful impact in the healthcare industry.

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.