In-Process QC Analyst – Biotech Manufacturing (Contract)

biomarin; Novato (CA); On-site; USD 75,000 - 120,000; Full time

Job summary

BioMarin is seeking a Quality Control Analytical In-Process (QCA-IP) Analyst on a contract basis to support analytical testing of in-process intermediates under cGMP guidelines. This role focuses on protein determination by A280, Bradford, UV, HPLC/UPLC, and method validation in a fast-paced manufacturing environment.

You will perform assays, manage sample throughput, assist with trend analysis, maintain lab supplies, and train less experienced staff while ensuring compliance and timely

Qualifications

• Bachelor of Science degree.
• 0-3 years of relevant laboratory experience; QC specific experience is preferred.
• Experience with quality management systems, current Good Manufacturing Practices, and QC principles.
• Demonstrated working knowledge with respect to certified functional activities.
• Good documentation, written and verbal communication skills are essential.
• Must possess the ability to perform most tasks with minimal supervision.
• Computer literacy in Microsoft Word and Excel; PowerPoint preferred.
• Familiarity with BINOCS or similar scheduling systems is preferred.
• Familiarity with SAP or similar enterprise systems is preferred.
• Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements.

Responsibilities

• Timely facilitation of incoming sample receipt and accessioning flow.
• Execute analytical methods to facilitate in-process testing under applicable cGMP guidelines and report results.
• Evaluate completed assay validity, summarize results, and assist with trend analysis reports.
• Maintain lab supplies and ensure systems for laboratory maintenance are adequate for readiness.
• Provide training to less experienced staff and ensure SOP compliance.
• Identify areas to improve operational excellence and reduce non-value-added activities.
• Assist with method validation, investigations, and transfer protocols.
• Attend team meetings and contribute to lab infrastructure improvements.

Education

Bachelor of Science degree

Tools

BINOCS

SAP

Excel

Job description

BioMarin is seeking a Quality Control Analytical In-Process (QCA-IP) Analyst on a contract basis to support analytical testing of in-process intermediates under cGMP guidelines. This role focuses on protein determination by A280, Bradford, UV, HPLC/UPLC, and method validation in a fast-paced manufacturing environment.

You will perform assays, manage sample throughput, assist with trend analysis, maintain lab supplies, and train less experienced staff while ensuring compliance and timely