QC Analytical Associate - HPLC / Biologics

About the Role

A Top-Tier Global Pharma Leader in Novato, CA is seeking a dedicated QC Analyst to perform critical analytical testing under cGMP guidelines to support commercial and clinical therapeutics.

Responsibilities

• Execute analytical methods (A280, Bradford, HPLC/UPLC) for in-process testing under cGMP guidelines.
• Facilitate incoming sample receipt, assay execution, and prompt reporting of results.
• Evaluate assay validity, analyze data, and assist with trend analysis reports.
• Initiate deviation investigation records and communicate compliance risks proactively.
• Maintain laboratory supplies, reagents, and equipment to ensure constant inspection readiness.
• Support test method validations, technical studies, and train junior laboratory staff.

Requirements

• Bachelor of Science degree in a relevant scientific discipline.
• 0-3 years of laboratory experience, with a solid understanding of cGMP principles.
• Proficiency in Good Documentation Practices (GDP) and strong communication skills.
• Ability to work independently under minimal supervision on a Wednesday-Saturday swing shift.
• Computer literacy, including proficiency in Microsoft Word and Excel.

Preferred Qualifications

• Prior Quality Control (QC) specific laboratory experience.
• Familiarity with enterprise software such as SAP and scheduling tools like BINOCS.

Skills

• Chemistry
• Ultra Performance Liquid Chromatography (UPLC)
• High Pressure Liquid Chromatography (HPLC)
• Good Laboratory Practices (GLP)
• Good Manufacturing Practices (GMP)

Schedule

4-day, 10-hour swing shift (Wednesday-Saturday, 1:00 PM-11:30 PM).

Pay

$30.00 - $31.03 per hour

Benefits

• Medical, prescription, dental, and vision insurance
• AD&D and life insurance
• Short-term disability
• 401K plan (all benefits are based on eligibility)