In-Process Analytical QC Analyst

BioSpace; Novato (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

BioMarin is seeking a Quality Control Analytical In-Process (QCA-IP) Analyst to perform analytical tests on in-process intermediates and drug products under cGMP. The role supports manufacturing for clinical and commercial therapeutics, including protein determination, enzyme activity, UV, HPLC/UPLC, and method validation.

The ideal candidate has a BS degree and up to 3 years of relevant lab experience, with strong documentation and communication skills, and familiarity with BINOCS or SAP

Qualifications

• Bachelor of Science degree.
• 0-3 years of relevant laboratory experience; QC experience preferred.
• Experience with quality management systems, cGMP, and QC principles.
• Demonstrated working knowledge of certified functional activities.
• Strong writing and verbal communication skills is essential.
• Ability to perform most tasks with minimal supervision.
• Proficiency with Microsoft Word and Excel.
• BINOCS or SAP familiarity is preferred.

Responsibilities

• Timely facilitation of incoming sample receipt and accessioning.
• Execute analytical methods for in-process testing under cGMP guidelines.
• Evaluate assay validity, summarize results, and assist trend analysis.
• Maintain lab housekeeping and readiness for inspections.
• Monitor inventory of laboratory supplies and reagents.
• Provide training for specified methods to staff.
• Escalate compliance risks and document investigations promptly.
• Support method validation, investigations, and transfer protocols.
• Participate in team meetings and propose infrastructure improvements.
• Identify opportunities to improve operational efficiency.
• Perform other duties as needed.

Skills

Attention to detail

Written communication

Verbal communication

Minimal supervision

Education

Bachelor of Science

Tools

BINOCS

SAP

Microsoft Word

Microsoft Excel

Job description

BioMarin is seeking a Quality Control Analytical In-Process (QCA-IP) Analyst to perform analytical tests on in-process intermediates and drug products under cGMP. The role supports manufacturing for clinical and commercial therapeutics, including protein determination, enzyme activity, UV, HPLC/UPLC, and method validation.

The ideal candidate has a BS degree and up to 3 years of relevant lab experience, with strong documentation and communication skills, and familiarity with BINOCS or SAP