Sterility Assurance Senior Consultant

Location: Kansas City, KS (onsite) Duration: 2-3 months Scope: This consulting role will perform detailed review of manufacturing, environmental monitoring, aseptic processing, deviation, complaint, and visual inspection data to support product impact assessments and retrospective lot evaluations.

Duties include: Execute lot-review activities in accordance with the approved protocol. Review manufacturing, environmental monitoring, aseptic processing, deviation, complaint, and visual-inspection data. Perform product-impact assessments and document conclusions. Identify recurring trends, adverse quality signals, and potential sterility-assurance concerns. Escalate findings requiring additional evaluation. Support development of technical justifications and final reports.

Years of Experience: 7 years

Key Experience Required: Sterility assurance, EM, aseptic processing, investigations, batch disposition assessments #LI-JH1 #LI-HYBRID We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.