Advanced Level Sterility Assurance Principal 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

Advanced Level Sterility Assurance Principal Specialist

JOB-10047624

Anticipated Start Date

October 5, 2026

Location

Berkeley, CA

Type of Employment

Contract

As a global leader in agriculture enterprise, our client is recognized for their multiple brands and renowned reputation. Their research and development teams combine knowledge and ingenuity to create the most innovative ideas. With their cutting-edge products, they have a common goal: improved quality of life for all.

Job Summary

If you're interested in a n Advanced Level Quality Professional job, then this is the best role for you! The Sterility Assurance Principal Specialist will provide senior individual contributor support for the Sterility Assurance and Contamination Control Program, focusing on program governance, metrics, action tracking, risk documentation, and inspection readiness. The role will collaborate with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT/Technical Operations, and QRM to translate the Contamination Control Strategy into practical deliverables and risk-based improvement activities.

Job Description

• 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.
• Support development of the Sterility Assurance and Contamination Control Program charter.
• Maintain the integrated CCS and sterility assurance roadmap and action tracker.
• Support quarterly Sterility Assurance health dashboards and periodic program execution summaries.

Skills Required

• Minimum 8 years of experience in pharmaceutical, biotechnology, biologics, sterile manufacturing, cell therapy, or aseptic processing environments.
• Strong understanding of GMP quality systems, deviations, CAPA, change control, risk management, documentation, and inspection readiness.
• Strong knowledge of contamination control and sterility assurance principles.
• Experience supporting cross-functional programs, action trackers, dashboards, risk registers, and leadership updates.
• Experience working with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT, or Technical Operations teams.
• Strong technical writing and documentation skills.
• Strong organization, facilitation, communication, and follow-through skills.
• Ability to translate complex technical risks into clear program actions.
• Strong risk-based thinking and inspection-readiness mindset.
• Experience with risk assessment tools such as FMEA, HACCP, fault tree analysis, risk registers, or risk-based prioritization.
• Ability to coordinate multiple stakeholders and deliverables effectively.
• Experience supporting contamination control, sterility assurance, quality systems, validation, QC Microbiology, manufacturing technical support, or GMP program execution.
• Experience with Contamination Control Strategy development, implementation, or periodic review preferred.
• Experience in aseptic manufacturing, environmental monitoring, APS/media fills, cleaning/disinfection programs, microbial investigations, or facility contamination control preferred.
• Experience supporting regulatory inspections, audit responses, or inspection-readiness programs preferred.

Education/Training/Certifications

• Bachelor’s degree in Microbiology, Biology, Biotechnology, Engineering, Pharmaceutical Sciences, or a related scientific or technical field.
• Familiarity with EU GMP Annex 1, FDA aseptic processing guidance, ICH Q9/Q10, PDA technical reports, and ISO cleanroom standards.

Additional Requirements

• Must be able to pass drug screenings and criminal background checks
• Start Time: 09:00 AM
• Ability to work as a senior individual contributor without people management responsibilities.
• Contract duration: 12–18 months, with potential extension based on program deliverables and business needs.

Pay Rate/Salary

• Estimated Salary: $55.51 to $63.51 per hour. Compensation will be offered within this posted range based on experience, skills, and market factors.

HarveStaff LLC is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.