Sterility Assurance Lead – Aseptic Investigations (Hybrid)

ProPharma; Raleigh (NC); Hybride; USD 90 000 - 130 000; Temps partiel

Résumé du poste

ProPharma seeks an experienced quality operations consultant to support manufacturing and sterility programs. The role involves reviewing manufacturing data, environmental monitoring, aseptic processing, deviations, complaints, and visual inspections to support product impact assessments.

You will execute lot-review activities, document conclusions, identify recurring trends and sterility concerns, escalate findings, and help develop technical justifications and final reports.

Qualifications

• 7+ years of experience in quality/sterility programs.
• Experience reviewing manufacturing, EM, aseptic processing, deviations, complaints, and visual inspections.
• Ability to perform product-impact assessments and document conclusions.
• Identify recurring trends, adverse quality signals, and sterility-related concerns.
• Escalate findings requiring additional evaluation.
• Support development of technical justifications and final reports.

Responsabilités

• 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.

Connaissances

Sterility assurance

Environmental monitoring

Aseptic processing

Investigations

Batch disposition assessments

Description du poste

ProPharma seeks an experienced quality operations consultant to support manufacturing and sterility programs. The role involves reviewing manufacturing data, environmental monitoring, aseptic processing, deviations, complaints, and visual inspections to support product impact assessments.

You will execute lot-review activities, document conclusions, identify recurring trends and sterility concerns, escalate findings, and help develop technical justifications and final reports.