Sterility Assurance Lead - Hybrid, Contamination Control

Dexian; Alameda (CA); Hybrid; USD 79,000 - 81,000; Full time

Job summary

Dexian seeks a Sterility Assurance Principal Specialist (Hybrid) in Berkeley, CA to provide senior IC support for Sterility Assurance and Contamination Control programs. You will help govern, track actions, assess risks, and drive inspection readiness across multiple teams including Quality, QC Microbiology, Manufacturing, and Validation.

Join a cross-functional effort to translate strategy into actionable deliverables, governance materials, and risk-based improvements, ensuring robust

Qualifications

• 8+ years in pharmaceutical/biotech sterile environments.
• GMP quality systems, deviations, CAPA knowledge.
• Experience with cross-functional programs and dashboards.

Responsibilities

• Support Sterility Assurance and Contamination Control program implementation and governance.
• Maintain action trackers, risk ranking, due dates, and escalation needs.
• Prepare materials for Sterility Assurance Council and leadership updates.
• Collaborate with Quality Risk Management to document and prioritize contamination control risks.
• Develop and monitor site-level sterility assurance metrics from multiple sources.
• Produce health summaries highlighting risk signals, gaps, CAPA effectiveness, and inspection readiness.

Skills

Communication skills

Cross-functional collaboration

Technical writing

Education

Bachelor's degree in Microbiology/Engineering/Pharma-related field

Job description

Dexian seeks a Sterility Assurance Principal Specialist (Hybrid) in Berkeley, CA to provide senior IC support for Sterility Assurance and Contamination Control programs. You will help govern, track actions, assess risks, and drive inspection readiness across multiple teams including Quality, QC Microbiology, Manufacturing, and Validation.

Join a cross-functional effort to translate strategy into actionable deliverables, governance materials, and risk-based improvements, ensuring robust