Sterility Assurance Senior Consultant

Location: Kansas City, Kansas, United States — onsite

Duration: 2–3 months

Company

hirify.global provides consulting and expertise across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.

What you will do

• Execute lot-review activities according to approved protocols.
• 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 technical justifications and final reports.

Requirements

• Seven years of professional experience.
• Experience in sterility assurance.
• Experience with environmental monitoring and aseptic processing.
• Experience conducting investigations.
• Experience with batch disposition assessments.
• Ability to work onsite in Kansas City, Kansas.

Culture & Benefits

• Inclusive workplace focused on diversity, equity, and inclusion.
• Collaborative and entrepreneurial working environment.
• Applications are personally reviewed by the recruitment team.
• Applicants receive an outcome regarding their application.