Quality Control Validations Specialist

About the role

We are seeking a detail-oriented QC Analytical Scientist to drive method validation and analytical transfer in a fast-paced cGMP environment. If you thrive on solving complex technical challenges and maintaining laboratory excellence, this is the dynamic opportunity for you.

Location: Newbury Park, California
Job type: Contract
Work hours: 9 to 5

Responsibilities

• Drive analytical method validation and transfer for laboratory methodologies, including raw materials qualification.
• Support test plan execution, discrepancy resolution, and completion approvals.
• Maintain laboratory equipment in a validated state and support installation, operational qualification (IOQ), and troubleshooting.
• Generate protocols, technical reports, and regulatory documentation using sound statistical techniques.
• Ensure all analytical methods meet internal standards, cGMP, and regulatory requirements (21CFR, USP, ICH).

Requirements

• Bachelor's Degree in Biotechnology, Microbiology, Pharmacy, Chemistry, or equivalent.
• Minimum 1 year of analytical development/validation experience in a pharmaceutical or biopharmaceutical manufacturing environment (or an advanced degree).
• Strong working knowledge of cGMP, lab unexpected results investigations, and regulatory standards (21CFR, USP, ICH).
• Demonstrated technical writing skills and ability to perform statistical data analysis.

Skills

• Good Manufacturing Practices (GMP)
• Deviation Investigation
• Process Validation
• Quality Control (QC)
• Food and Drug Administration (FDA)
• International Council for Harmonization (ICH)

Pay

$50 - 62 per hour

Benefits

• Medical, prescription, dental, and vision insurance
• AD&D and life insurance
• Short-term disability
• 401K plan