Sterility Assurance Principal Specialist - Senior IC (12–18 mo)

US Tech Solutions; Berkeley (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

US Tech Solutions in Berkeley is seeking a Sterility Assurance Principal Specialist to provide senior individual contributor support for the Site Sterility Assurance and Contamination Control Program. This 12-18 month contract role focuses on program governance, metrics, action tracking, risk documentation, and inspection-readiness.

You will partner with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT/Technical Operations, and QRM to translate the Contamination

Qualifications

• Minimum 8 years of experience in pharmaceutical, biotechnology, sterile manufacturing, or aseptic processing.
• Experience in contamination control, sterility assurance, quality systems, validation, or GMP program execution.
• Strong cross-functional collaboration and technical writing skills.

Responsibilities

• Support continued implementation of Berkeley Site Sterility Assurance and Contamination Control Program, including roadmap, workstream tracking, governance materials, and execution follow-up.
• Maintain the site CCS / sterility assurance action tracker, including owners, due dates, dependencies, risk ranking, progress updates, and escalation needs.
• Prepare periodic 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.
• Support development of site-level sterility assurance metrics by integrating existing source data from QA, QC Microbiology, Engineering, Manufacturing, Validation, and Operations without duplicating dashboards.
• Prepare health summaries highlighting key risk signals, overdue actions, repeat contamination patterns, CAPA effectiveness, and inspection-readiness status.
• Assist with inspection-readiness activities related to CCS, contamination control governance, QRM linkage, risk-based decisions, and CAPA tracking.
• Support development of program-level tools such as charters, templates, decision trees, governance triggers, risk review forms, dashboards, and communication materials.
• Coordinate delivered work across cross-functional stakeholders with clear documentation and escalation of risks or overdue items.

Skills

Sterility assurance

Contamination control

Quality systems

GMP

Risk management

Documentation

Cross-functional

Technical writing

Dashboards

Education

Bachelor's degree in microbiology or related field

Tools

Excel

Job description

US Tech Solutions in Berkeley is seeking a Sterility Assurance Principal Specialist to provide senior individual contributor support for the Site Sterility Assurance and Contamination Control Program. This 12-18 month contract role focuses on program governance, metrics, action tracking, risk documentation, and inspection-readiness.

You will partner with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT/Technical Operations, and QRM to translate the Contamination