Senior Sterility Assurance and Contamination Specialist

Harvestaff; Berkeley (CA); On-site; USD 76,000 - 87,000; Part time

Job summary

HarveStaff LLC is seeking an Advanced Level Sterility Assurance Principal Specialist in Berkeley, CA. The role focuses on governance, metrics, action tracking, risk documentation, and inspection readiness within the Sterility Assurance and Contamination Control Program.

You will partner with multiple departments to translate the Contamination Control Strategy into practical deliverables and risk-based improvements, while maintaining dashboards, health summaries, and a robust action tracker.

Qualifications

• Strong understanding of GMP quality systems, deviations, CAPA, change control, risk management, documentation, and inspection readiness.
• Experience supporting cross-functional programs, action trackers, dashboards, risk registers, and leadership updates.
• Ability to translate complex technical risks into clear program actions.

Responsibilities

• Support implementation and ongoing execution of the Sterility Assurance and Contamination Control Program.
• Maintain the CCS and sterility assurance action tracker, including owners, due dates, dependencies, risk rankings, progress updates, and escalation needs.
• Prepare Sterility Assurance Council agendas, action logs, decision records, risk summaries, and leadership updates.
• Partner with QRM stakeholders to document, prioritize, escalate, and review contamination control risks.
• Develop site-level sterility assurance metrics using existing data from QA, QC Microbiology, Engineering, Manufacturing, Validation, and Operations.
• Prepare periodic Sterility Assurance and Contamination Control health summaries.
• Track high-risk gaps, overdue actions, repeat contamination patterns, CAPA effectiveness, and inspection-readiness status.
• Support inspection-readiness activities related to CCS, contamination control governance, QRM, risk-based decisions, CAPA tracking, and program maturity.
• Develop and revise program-level tools, including charters, templates, decision trees, governance triggers, risk review forms, dashboards, and communication materials.
• Coordinate cross-functional deliverables and ensure appropriate documentation, follow-up, and escalation.

Skills

GMP quality systems

Risk management

Documentation skills

Cross-functional collaboration

Program governance

Education

Bachelor's degree in Microbiology or related

Job description

HarveStaff LLC is seeking an Advanced Level Sterility Assurance Principal Specialist in Berkeley, CA. The role focuses on governance, metrics, action tracking, risk documentation, and inspection readiness within the Sterility Assurance and Contamination Control Program.

You will partner with multiple departments to translate the Contamination Control Strategy into practical deliverables and risk-based improvements, while maintaining dashboards, health summaries, and a robust action tracker.