QC Validation Scientist — Method Validation & Analysis

Katalyst CRO; Thousand Oaks (CA); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading contract research organization in Thousand Oaks, California, is seeking an experienced professional for analytical method validation. The role demands at least 7 years of experience in analytical development within pharmaceutical settings, a strong understanding of regulatory standards, and proficiency in technical writing. Responsibilities include driving validation efforts, maintaining laboratory equipment, and supporting troubleshooting of analytical methods. Candidates should possess a Bachelor's degree in a relevant field. Competitive compensation and benefits package offered.

Qualifications

• Minimum of 7 years of experience in analytical development or validation.
• Experience in reviewing and approving Life Cycle Validation Documents.
• Familiar with commissioning, Installation, Operational and Performance Qualification protocols.

Responsibilities

• Drive analytical method validation and transfer laboratory methodologies.
• Ensure laboratory equipment maintains a validated state.
• Support troubleshooting of analytical methods.

Skills

Strong technical writing skills

Knowledge of analytical methods

Knowledge about analytical method validation

Intermediate statistical knowledge

Knowledge concerning cGMP

Basic regulatory requirements knowledge

Proficient in Microsoft Office

Strategically and business-oriented thinking

Education

Bachelor's degree in Biotechnology, Microbiology, Pharmacy, Chemistry

Tools

Paperless validation software

Microsoft Office

Job description

A leading contract research organization in Thousand Oaks, California, is seeking an experienced professional for analytical method validation. The role demands at least 7 years of experience in analytical development within pharmaceutical settings, a strong understanding of regulatory standards, and proficiency in technical writing. Responsibilities include driving validation efforts, maintaining laboratory equipment, and supporting troubleshooting of analytical methods. Candidates should possess a Bachelor's degree in a relevant field. Competitive compensation and benefits package offered.