Sterility Assurance Lead

The Sterility Assurance Lead is responsible for leading and maintaining site-wide sterility assurance and contamination control programs within a sterile pharmaceutical manufacturing environment. This role provides technical leadership and oversight for terminally sterilized and injectable drug product operations, ensuring compliance with FDA aseptic processing guidance, EU Annex 1, cGMP standards, and global regulatory requirements. The position serves as the site Subject Matter Expert (SME) for sterility assurance, environmental monitoring, microbiological risk management, and contamination control strategies while supporting process validation, regulatory inspections, and continuous improvement initiatives.

Location: Raleigh NC

Salary: $90,000-$110,000/year

Direct Hire role

No relocation assistance offered

Key Responsibilities

Sterility Assurance & Contamination Control

• Develop, implement, and maintain sterility assurance and contamination control programs for sterile manufacturing operations
• Lead the site Contamination Control Strategy (CCS) and ensure alignment with regulatory expectations and industry best practices
• Serve as SME for sterility assurance, microbiological oversight, and contamination control activities
• Define and monitor microbiological and particulate alert/action limits
• Ensure environmental monitoring programs are effectively designed, executed, evaluated, and maintained throughout the product lifecycle
• Support inspection readiness and participate in regulatory inspections and audits as the sterility assurance SME
• Prepare and support responses to regulatory observations related to sterility assurance and contamination control
  
  

Process Oversight, Validation & Qualification

• Provide oversight for terminal sterilization and aseptic manufacturing processes across development, validation, and commercial operations
• Review and approve critical manufacturing and sterilization activities including washing, filling, sterilization cycles, and environmental controls
• Review and approve validation strategies, protocols, and reports including IQ/OQ/PQ activities
• Ensure appropriate microbiological and particulate control strategies are established and maintained
• Support ongoing process verification and continued process monitoring activities
  
  

Investigations, Risk Assessment & CAPA

• Lead or support investigations involving microbiological deviations, contamination events, and sterility-related nonconformances
• Conduct and review risk assessments related to sterility assurance and contamination control
• Drive development and implementation of CAPAs to mitigate contamination and sterility risks
• Monitor trends and recurring issues to identify and address systemic risks
  
  

Cross-Functional Collaboration & Training

• Partner with Manufacturing, Engineering, Validation, Quality Control Microbiology, and Quality Assurance teams to ensure effective sterility assurance integration
• Provide coaching, training, and guidance on contamination control principles, aseptic behaviors, and sterility assurance best practices
• Support development and revision of SOPs, work instructions, and training materials
• Promote a strong quality culture focused on compliance, contamination control, and operational excellence
  
  

Continuous Improvement & Operational Support

• Participate in operational excellence and continuous improvement initiatives
• Support technology transfers, new product introductions, and cross-functional projects
• Assist with internal audits, gap assessments, and periodic reviews of sterility assurance systems
• Support departmental and site objectives as assigned
  
  

Qualifications

Education

• Bachelor’s or Master’s degree in Microbiology, Pharmaceutical Sciences, Biotechnology, Engineering, or related scientific discipline
  
  

Experience

• Minimum 5 years of experience in sterile pharmaceutical manufacturing, injectable products, or terminal sterilization environments
• Experience supporting aseptic processing and/or terminal sterilization operations
• Strong knowledge of microbiology principles, contamination control, and cleanroom manufacturing
• Experience supporting validation, qualification, and regulatory compliance activities
  
  

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

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About Kelly

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