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

• 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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) 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? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed. About Kelly Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year. Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment\_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.