What are the responsibilities and job description for the Sterility Assurance Lead position at Kelly?
Job Title: Sterility Assurance Lead
Location: Raleigh (Onsite)
Compensation: $105,000 – $125,000 base salary (flexible based on experience) bonus potential
Position Overview
We are seeking a Sterility Assurance Lead to own and drive the site’s sterility assurance strategy for sterile injectable products manufactured in classified environments with terminal sterilization processes. This is a high-impact role responsible for contamination control, microbiological oversight, and regulatory readiness in alignment with FDA guidance and EU GMP Annex 1.
This individual will serve as the site Subject Matter Expert (SME) and play a critical role in ensuring inspection readiness, advancing contamination control strategies, and continuously improving sterility assurance systems.
Key Responsibilities
Sterility Assurance & Contamination Control
- Lead and maintain the site-wide sterility assurance program
- Own and continuously improve the Contamination Control Strategy (CCS)
- Establish and monitor microbiological and particulate limits
- Ensure alignment with FDA aseptic processing guidance and EU Annex 1
- Serve as SME during regulatory inspections and audits
Environmental Monitoring & Program Ownership
- Own the Environmental Monitoring Performance Qualification (EMPQ) program
- Oversee lifecycle management including design, execution, trending, and optimization
- Ensure effectiveness of environmental monitoring and contamination controls
Process Oversight & Validation
- Provide sterility assurance oversight across the product lifecycle
- Review and approve critical processes (washing, filling, sterilization)
- Approve validation strategies and documentation (IQ/OQ/PQ)
- Ensure robust contamination control prior to sterilization
Investigations, Risk & CAPA
- Lead investigations related to contamination events and microbiological deviations
- Perform risk assessments using structured tools (FMEA, HACCP)
- Implement and monitor corrective and preventive actions (CAPA)
- Identify trends and drive systemic improvements
Cross-Functional Leadership
- Partner with Production, Engineering, QC Microbiology, Validation, and QA
- Provide training on aseptic practices and contamination control
- Drive a strong quality and sterility assurance culture across the site
Qualifications
Required
- Bachelor’s or Master’s degree in Microbiology, Pharmaceutical Sciences, Biotechnology, Engineering, or related field
- 5 years of experience in sterile or injectable pharmaceutical manufacturing
- Experience with terminal sterilization and/or aseptic processing
- Strong knowledge of microbiology and contamination control principles
- Experience working in cleanroom environments
Preferred
- Experience supporting FDA or international regulatory inspections
- Experience with EU GMP Annex 1 implementation or remediation
Salary : $105,000 - $125,000