Quality Professional - Sterility Assurance (Hybrid)

Dexian; Berkeley (CA); Hybrid; USD 180,000 - 230,000; Full time

Job summary

Dexian seeks a Sterility Assurance Principal Specialist to lead the Sterility Assurance and Contamination Control program with senior-level accountability. You will partner with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT, and Quality Risk Management to translate strategies into actionable plans and governance materials.

You will drive metrics, action tracking, risk documentation, and inspection-readiness efforts, delivering clear documentation and

Qualifications

• Bachelor's degree in a science/engineering field.
• 8+ years in pharma/biotech sterile environments.
• Experience supporting contamination control, sterility assurance, quality systems, validation, QC Microbiology, or GMP program execution.
• Strong understanding of GMP quality systems, deviations, CAPA, change control, risk management, documentation, and inspection readiness.
• Demonstrated experience supporting 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 implementation of the Sterility Assurance and Contamination Control Program, including roadmap, workstream tracking, governance materials, and execution follow-up.
• Maintain CCS and sterility assurance action trackers with owners, due dates, dependencies, risk ranking, progress updates, and escalations.
• Prepare Sterility Assurance Council materials, including agendas, action logs, decision records, risk summaries, and leadership updates.
• Collaborate with Quality Risk Management to document, prioritize, escalate, and review contamination control risks.
• Develop site-level sterility assurance metrics by integrating QA, QC Microbiology, Engineering, Manufacturing, Validation, and Operations data.
• Produce periodic health summaries highlighting risk signals, gaps, overdue actions, contamination patterns, CAPA effectiveness, and readiness status.
• Assist with inspection-readiness activities related to CCS, governance, risk management, CAPA tracking, and program maturity.
• Develop and revise program tools such as charters, templates, decision trees, governance triggers, risk review forms, dashboards, and communications.

Skills

Cross-functional coordination

GMP documentation discipline

Risk-based thinking

Inspection-readiness mindset

Technical writing

Program governance

Stakeholder management

Education

Bachelor's degree in Microbiology, Biology, Biotechnology, Engineering, Pharmaceutical Sciences, or related field

Tools

FMEA

HACCP

Risk registers

Job description

Job Title: Quality Professional -Sterility Assurance Principal Specialist (Hybrid)

Position Summary

We are seeking a Sterility Assurance Principal Specialist to provide senior individual contributor support for a Sterility Assurance and Contamination Control Program. This role will support program structure, governance, metrics, action tracking, risk documentation, and inspection-readiness activities across contamination control and sterility assurance workstreams.

The position will partner with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT/Technical Operations, and Quality Risk Management teams to translate the Contamination Control Strategy into practical deliverables, action plans, governance materials, and risk-based improvement activities.

Key Responsibilities

• Support implementation of the Sterility Assurance and Contamination Control Program, including roadmap, workstream tracking, governance materials, and execution follow-up.
• Maintain CCS and sterility assurance action trackers, including 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 Quality Risk Management stakeholders to ensure contamination control risks are documented, prioritized, escalated, and reviewed using established risk-management processes.
• Support development of site-level sterility assurance metrics by integrating source data from QA, QC Microbiology, Engineering, Manufacturing, Validation, and Operations.
• Prepare periodic Sterility Assurance and 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, risk management, 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.

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 experience supporting 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 (CCS) 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.

Core Competencies

• Cross-functional coordination
• GMP documentation discipline
• Risk-based thinking
• Inspection-readiness mindset
• Strong follow-through
• Ability to translate complex technical risks into clear program actions

Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.

Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals. To learn more, please visit https://dexian.com/.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.