Quality Control In Process in Irvine

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Job DescriptionJob Description

Quality Control Analyst – In-Process Testing

Position Overview

Join a dynamic and mission-driven team focused on the development and manufacture of critical biopharmaceutical products. The In-Process Quality Control Analyst plays an essential role in supporting manufacturing, validation, process development, and stability programs within a GMP-regulated laboratory environment.

This position is responsible for performing in-process testing, sampling, and data analysis while ensuring strict compliance with established procedures and regulatory standards.

Key Responsibilities

• Conduct routine compendial testing independently, following approved protocols
• Accurately analyze, document, and report laboratory results
• Prepare buffers, reagents, and solutions required for testing
• Draft, review, and update analytical methods and SOPs
• Perform aseptic sampling and in-process analyses including:
• • Endotoxin (LAL)
  • pH
  • Conductivity
  • Osmolality
  • A280
• Execute water testing, raw material sampling, and associated analyses
• Support lot release, stability studies, development/validation projects, and investigations
• Author study protocols, technical reports, and related documentation
• Collaborate cross-functionally to develop and improve QC procedures and policies
• Retrieve and manage samples in accordance with written procedures
• Maintain compliance with cGMP regulations and applicable industry standards
• Perform additional duties as assigned

Required Qualifications

• Bachelor’s degree in Biochemistry, Chemistry, Biology, or a related scientific discipline
• Minimum of 2 years of experience in a biotechnology QC or analytical laboratory
• Hands-on experience with analytical testing in a GMP environment
• Experience writing reports and supporting regulatory audits
• Familiarity with most of the analytical techniques listed above
• Experience with troubleshooting and maintaining laboratory instrumentation is

Work Schedule

• Full-time, Wednesday through Saturday
• 4x10 schedule (four 10-hour shifts per week)
• Flexibility required to support operational needs
• Overtime and occasional weekend coverage may be required

Compensation & Benefits

• Hourly pay range: $24-$33, based on experience and qualifications
• Performance-based bonus opportunities
• Comprehensive medical, dental, and vision coverage
• 401(k) with company match
• Paid time off
• Career development and advancement opportunities
• Inclusive and collaborative work environment

What We’re Looking For

• A proactive, team-oriented mindset
• Strong written and verbal communication skills
• Excellent organizational and multitasking abilities
• High level of attention to detail
• Ability to build and maintain effective working relationships

If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.