Senior Sterility Assurance Specialist – Contamination Control (Hybrid)

Syndicus, Inc.; Berkeley (CA); Hybrid; USD 48,000 - 80,000; Full time

Job summary

Syndicus, Inc. seeks a Sterility Assurance Principal Specialist to support the Berkeley Site Sterility Assurance and Contamination Control Program.

This senior individual contributor role focuses on governance, risk documentation, and inspection-readiness across multiple workstreams. The role collaborates with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT, and QRM to translate the Contamination Control Strategy into concrete deliverables, dashboards, and

Qualifications

• Bachelor’s degree in microbiology, biology, biotechnology, engineering, pharmaceutical sciences, or related field.
• Minimum 8 years of experience in pharmaceutical, biotechnology, biologics, sterile manufacturing, cell therapy, or aseptic processing environments.
• Experience supporting contamination control, sterility assurance, quality systems, validation, QC Microbiology, manufacturing technical support, or GMP program execution.
• Strong understanding of GMP quality systems, deviations, CAPA, change control, risk management, documentation, and inspection readiness.
• Demonstrated ability to support cross-functional programs, action trackers, dashboards, risk registers, and leadership updates.
• Experience working with stakeholders across Quality, QC, Manufacturing, Engineering, Validation, Facilities, MSAT, or Technical Operations.

Responsibilities

• Support continued implementation of the Berkeley Site Sterility Assurance and Contamination Control Program, including program roadmap, workstream tracking, governance materials, and execution follow-up.
• Maintain the site CCS / sterility assurance action tracker, including assigned owners, due dates, dependencies, risk ranking, progress updates, and escalation needs.
• Support preparation of Sterility Assurance Council materials, including agendas, action logs, decision records, risk summaries, and leadership updates.
• Partner with the QRM program/SME to ensure contamination control risks are documented, prioritized, escalated, and reviewed using approved site risk-management processes.
• Prepare periodic Sterility Assurance / Contamination Control health summaries highlighting key risk signals, open high-risk gaps, overdue actions, repeat contamination patterns, CAPA effectiveness, and inspection-readiness status.

Job description

Syndicus, Inc. seeks a Sterility Assurance Principal Specialist to support the Berkeley Site Sterility Assurance and Contamination Control Program.

This senior individual contributor role focuses on governance, risk documentation, and inspection-readiness across multiple workstreams. The role collaborates with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT, and QRM to translate the Contamination Control Strategy into concrete deliverables, dashboards, and