US- Quality Professional (Advanced) - Sterility Assurance Principal Specialist

Job Title: Sterility Assurance Principal Specialist
Duration: 12 MONTHS
Location: Berkeley, CA

Job Description:
The role will partner with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT/Technical Operations, and QRM to help translate the site Contamination Control Strategy into practical deliverables, action plans, governance materials, and risk-based improvement activities. This is an individual contributor specialist role and does not include people management responsibilities.

Contract Duration
12–18 months, with potential extension based on program deliverables and business need.

Key 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.
Support development of site-level sterility assurance metrics by integrating existing source data from QA, QC Microbiology, Engineering, Manufacturing, Validation, and Operations without duplicating functional dashboards.
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.
Assist with inspection-readiness activities related to CCS, contamination control governance, QRM linkage, risk-based decisions, CAPA tracking, and sterility assurance program maturity.
Support development and revision of program-level tools such as charters, templates, decision trees, governance triggers, risk review forms, dashboards, and communication materials.
Coordinate assigned deliverables across cross-functional stakeholders while maintaining clear documentation, follow-up, and escalation of risks or overdue items.

Expected Deliverables
Sterility Assurance and Contamination Control Program charter support.
Integrated CCS / sterility assurance roadmap and action tracker.
Sterility Assurance Council agendas, action logs, and governance outputs.
Contamination control risk register interface with QRM.
Quarterly Sterility Assurance health dashboard.
Periodic summary of open high-risk gaps, overdue actions, and program execution status.

Required Qualifications
Bachelor’s degree in microbiology, biology, biotechnology, engineering, pharmaceutical sciences, or a related scientific/technical 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.
Strong technical writing, organization, facilitation, and communication skills.

Preferred Qualifications
Experience with Contamination Control Strategy development, implementation, or periodic review.
Experience in aseptic manufacturing, environmental monitoring, APS/media fills, cleaning/disinfection programs, microbial investigations, or facility contamination control.
Familiarity with EU GMP Annex 1, FDA aseptic processing guidance, ICH Q9/Q10, PDA technical reports, ISO cleanroom standards, and industry expectations for contamination control.
Experience supporting regulatory inspections, audit responses, or inspection-readiness programs.
Experience with risk tools such as FMEA, HACCP, fault tree analysis, risk registers, or risk-based prioritization.