Amanda Trusiak
Biomedical Engineer | CCIT Program Manager
- Role
- Ccit Program Manager at Gateway Analytical, An Aptar Pharma Company
- Location
- Pittsburgh, PA, US
- LinkedIn followers
- 500 followers
About Amanda Trusiak
Biomedical Engineering professional with experience in FDA-regulated product development,…
Experience
Ccit Program Manager
Gateway Analytical, An Aptar Pharma Company
Aug 2024 — Present · Gibsonia, PA, US
Serves as department lead for CCIT (Container Closure Integrity Testing), managing project assignment, scientist oversight, timelines, client communication, and laboratory operations.• Leads method development and validation in alignment with USP 1225 and analytical instrument qualification per USP 1058.• Ensures compliance with USP1207 for package integrity evaluation and USP382 for elastomeric closure functionality, while upholding strict GMP standards.• Conducts technical reviews of analytical reports to ensure scientific accuracy and regulatory alignment.• Leads the initiation and coordination of quality events such as CAPAs, deviations, OOS investigations, change controls, and SOP revisions.• Hosts regulatory and customer audits as the technical SME for validated CCIT methods.• Develops training materials for sample preparation, analysis, and interpretation of data.• Reports financial summaries of monthly revenue, labor utilization and ROI of services for the CCIT department.
Education
Duquesne University
Master of Science
2021 — 2022
Duquesne University
Bachelor of Science
2017 — 2021
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