Senior Sterility Assurance & Contamination Control

Rose International; Berkeley (CA); Hybrid; USD 110,000 - 123,000; Full time

Job summary

Rose International in Berkeley, CA is seeking a Principal Sterility Assurance & Contamination Control Specialist to advance the site's CCS, governance, risk management and inspection readiness. This senior individual contributor role works with Quality, QC Microbiology, Manufacturing, Engineering and Validation to turn complex contamination-control risks into clear action plans and measurable improvements.

The position does not include people management.

Qualifications

• 8+ years in pharmaceutical/biotech GMP environments.
• Experience supporting sterility assurance, contamination control and QA systems.
• Strong knowledge of GMP quality systems, deviations, CAPA and risk management.

Responsibilities

• Support Sterility Assurance and Contamination Control program maturity.
• Maintain CCS roadmap, action tracker, risk rankings and governance.
• Prepare materials for governance meetings and leadership updates.
• Partner with Quality Risk Management to document and elevate risks.
• Integrate data from Quality, QC Microbiology, Manufacturing and Validation to support metrics.
• Develop health summaries on high-risk gaps and CAPA effectiveness.
• Support inspection-readiness activities and program maturity.
• Create and improve program tools like templates, dashboards and charters.

Skills

Environmental Reporting

GMP

Pharmaceutical

Quality Control (QC)

Risk Analysis

Education

Bachelor's Degree

Job description

Rose International in Berkeley, CA is seeking a Principal Sterility Assurance & Contamination Control Specialist to advance the site's CCS, governance, risk management and inspection readiness. This senior individual contributor role works with Quality, QC Microbiology, Manufacturing, Engineering and Validation to turn complex contamination-control risks into clear action plans and measurable improvements.

The position does not include people management.