Principal Sterility Assurance & Contamination Control Specialist

Rose International; Berkeley (CA); Hybrid; USD 110,000 - 123,000; Full time

Job summary

Rose International in Berkeley, CA is seeking a Principal Sterility Assurance & Contamination Control Specialist to advance the site's CCS, governance, risk management and inspection readiness. This senior individual contributor role works with Quality, QC Microbiology, Manufacturing, Engineering and Validation to turn complex contamination-control risks into clear action plans and measurable improvements.

The position does not include people management.

Qualifications

• 8+ years in pharmaceutical/biotech GMP environments.
• Experience supporting sterility assurance, contamination control and QA systems.
• Strong knowledge of GMP quality systems, deviations, CAPA and risk management.

Responsibilities

• Support Sterility Assurance and Contamination Control program maturity.
• Maintain CCS roadmap, action tracker, risk rankings and governance.
• Prepare materials for governance meetings and leadership updates.
• Partner with Quality Risk Management to document and elevate risks.
• Integrate data from Quality, QC Microbiology, Manufacturing and Validation to support metrics.
• Develop health summaries on high-risk gaps and CAPA effectiveness.
• Support inspection-readiness activities and program maturity.
• Create and improve program tools like templates, dashboards and charters.

Skills

Environmental Reporting

GMP

Pharmaceutical

Quality Control (QC)

Risk Analysis

Education

Bachelor's Degree

Job description

• Date Posted: 09/21/2026
• Hiring Organization: Rose International
• Position Number: 507833
• Industry: Biotech/Healthcare
• Job Title: Principal Sterility Assurance & Contamination Control Specialist
• Job Location: Berkeley, CA, USA, 94710
• Work Model: Hybrid
• Work Model Details: TBD at this time
• Shift: Monday-Friday, 9:00am Start, 8-hour shifts
• Employment Type: Temporary
• FT/PT: Full-Time
• Estimated Duration (In months): 12
• Min Hourly Rate($): 53.00
• Max Hourly Rate($): 59.00
• Must Have Skills/Attributes: Environmental Reporting, GMP, Pharmaceutical, Quality Control (QC), Risk Analysis
• Experience Desired: Aseptic manufacturing or sterile processing knowledge (8+ yrs); QC Microbiology and environmental monitoring exposure (8+ yrs); GMP quality systems and risk management (8+ yrs); CAPA, deviations and change control (8+ yrs); Inspection/audit readiness (8+ yrs)
• Required Minimum Education: Bachelor's Degree
• **C2C is not available**

Job Description

Required Education

• Bachelor's degree in Microbiology, Biology, Biotechnology, Engineering, Pharmaceutical Sciences or a related scientific/technical field.

Required Qualifications

• 8+ years of experience in pharmaceutical, biotechnology, biologics, sterile manufacturing, cell therapy, aseptic processing or a related GMP environment.
• Experience supporting sterility assurance, contamination control, quality systems, validation, QC Microbiology, manufacturing technical support or GMP program execution.
• Strong knowledge of GMP quality systems, deviations, CAPA, change control, risk management and inspection readiness.
• Demonstrated experience coordinating cross-functional programs, action trackers, dashboards, risk registers and leadership updates.
• Experience partnering with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT or Technical Operations.
• Strong technical writing, organization, facilitation and communication skills.

Preferred Qualifications

• Experience developing, implementing or reviewing a Contamination Control Strategy.
• Experience with aseptic manufacturing, environmental monitoring, APS/media fills, cleaning and disinfection, microbial investigations or facility contamination control.
• Knowledge of EU GMP Annex 1, FDA aseptic processing guidance, ICH Q9/Q10, PDA technical reports and cleanroom standards.
• Experience supporting regulatory inspections, audit responses or inspection-readiness programs.
• Experience with FMEA, HACCP, fault-tree analysis, risk registers or other risk-based assessment methodologies.

Summary

Seeking an experienced Principal Sterility Assurance & Contamination Control Specialist to support the Berkeley site's Sterility Assurance and Contamination Control Program.

This senior individual contributor role will help drive the site's Contamination Control Strategy (CCS), program governance, risk management, metrics, action tracking and inspection readiness.

The successful candidate will work across Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT/Technical Operations and Quality Risk Management to turn complex contamination-control risks into clear action plans, governance decisions and measurable improvements.

This position does not have direct people-management responsibilities.

Responsibilities

• Support implementation and continued maturity of the Berkeley site's Sterility Assurance and Contamination Control Program.
• Maintain the site CCS roadmap and action tracker, including owners, deadlines, dependencies, risk rankings, progress and escalation requirements.
• Prepare materials for Sterility Assurance governance meetings, including agendas, action logs, decision records, risk summaries and leadership updates.
• Partner with Quality Risk Management stakeholders to document, prioritize and elevate contamination-control risks.
• Integrate relevant data from Quality, QC Microbiology, Manufacturing, Engineering, Validation and Operations to support meaningful sterility assurance metrics.
• Develop periodic Sterility Assurance and Contamination Control health summaries covering high-risk gaps, overdue actions, contamination trends, CAPA effectiveness and inspection readiness.
• Support inspection-readiness activities involving CCS, contamination-control governance, risk-based decisions, CAPA tracking and program maturity.
• Develop and improve program tools such as charters, templates, decision trees, risk-review forms, dashboards and governance materials.
• Coordinate complex deliverables across multiple technical and quality functions while maintaining strong documentation and follow-through.
• Identify risks, barriers and overdue activities and ensure appropriate escalation and resolution.
• Drug screen & criminal background check will be required
• **Only those lawfully authorized to work in the designated country associated with the position will be considered.**
• **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**

Benefits

For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.

California Pay Equity

For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.

Equality & Diversity Statement

Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

Accessibility & Assistance

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.

E-Verify

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).