Quality Control Analytical Scientist II

Job Summary

Are you ready to elevate your career with a top-tier biopharmaceutical leader? We are seeking a QC Analytical Scientist to drive analytical method development, instrument qualification, and quality control support within a cutting-edge cGMP environment. If you excel at solving complex analytical challenges and leading cross-functional site initiatives, this is your next career move.

location

Newbury Park, California

job type

Contract

salary

$50 - 62 per hour

work hours

9 to 5

education

Bachelor's Degree in Biotechnology, Microbiology, Pharmacy, Chemistry, or equivalent

Responsibilities

• Drive analytical method development, validation, and technology upgrades for laboratory methodologies and instrumentation.
• Lead the installation, operational qualification (IOQ), maintenance, and troubleshooting of AQC analytical instruments.
• Conduct and review laboratory investigations, providing scientific justification for initial Out of Specification (iOOS), Out of Trend (OOT), and atypical results.
• Author protocols, technical reports, and CMC submission documentation, including raw material qualifications.
• Support method transfers, execute assay control and critical reagent qualifications, and monitor method performance trends.
• Serve in project leadership roles across global and local site functions to ensure Right First Time (RFT) execution.

Qualifications

• Minimum of 3 years of analytical development or validation experience in a cGMP pharmaceutical or biopharmaceutical manufacturing environment (or an advanced degree).
• Strong background in method transfer, troubleshooting, and cGMP compliance.

skills

• SOP Development
• Good Manufacturing Practices (GMP)
• Quality Control (QC)

Benefits

• medical
• prescription
• dental
• vision
• AD&D
• life insurance
• short-term disability
• 401K plan