Senior Sterility Assurance Consultant (Aseptic/EM) – Hybrid

PPG US ProPharma Group, LLC; Nevada (IA); On-site; USD 83,000 - 117,000; Full time

Job summary

ProPharma is seeking an experienced reviewer for a 2-3 month onsite contract in Kansas City, KS. The role focuses on review of manufacturing and quality data to support product impact assessments and retrospective lot evaluations.

The ideal candidate has 7 years in sterile operations, with emphasis on sterility, environmental monitoring, aseptic processing, deviations, and investigations. Onsite collaboration with the team is expected with potential hybrid elements depending on project needs.

Qualifications

• 7 years of QA/Manufacturing experience in sterile or pharmaceutical environments.
• Experience with sterility assurance, EM, and aseptic processing.
• Experience performing investigations and batch disposition assessments.

Responsibilities

• Execute lot-review activities in accordance with the approved protocol.
• Review manufacturing, EM, aseptic processing, deviation, complaint, and visual-inspection data.
• Perform product-impact assessments and document conclusions.
• Identify recurring trends and potential sterility concerns.
• Escalate findings needing additional evaluation.
• Support development of technical justifications and final reports.

Skills

Sterility assurance

Environmental Monitoring

Aseptic processing

Investigations

Batch disposition assessments

Job description

ProPharma is seeking an experienced reviewer for a 2-3 month onsite contract in Kansas City, KS. The role focuses on review of manufacturing and quality data to support product impact assessments and retrospective lot evaluations.

The ideal candidate has 7 years in sterile operations, with emphasis on sterility, environmental monitoring, aseptic processing, deviations, and investigations. Onsite collaboration with the team is expected with potential hybrid elements depending on project needs.