Stephanie Lugo

Quality Specialist with 8+ years of experience supporting pharmaceutical manufacturing operations in FDA-regulated environments. Strong background in cGMP compliance, batch record documentation, validation support (IQ/OQ/PQ), document control systems, and quality oversight. Experienced in manufacturing floor support, documentation review, and ensuring data integrity in solid dosage production.

Recognized for attention to detail, compliance mindset, and ability to collaborate cross-functionally to maintain inspection readiness.

Intake Specialist / Case Manager at Pathstone (2022-01 – Present)

• Managed regulated documentation and confidential records in compliance with program standards.
• Prepared detailed reports to support audits and program reviews.
• Ensured accuracy, completeness, and traceability of case files and supporting documentation.
• Conducted workshops and provided financial counseling while maintaining structured documentation controls.

Manufacturing Operator – Solid Dosage at Heleon (2020-01 – 2022-01)

• Executed tablet coating operations following approved batch records and cGMP requirements.
• Prepared coating solutions and supported solid oral dosage manufacturing processes.
• Performed cleaning verification and line clearance activities to maintain compliance standards.
• Accurately completed batch production records ensuring data integrity and Good Documentation Practices (GDP).
• Supported deviation documentation and compliance-related activities within the production area.

Document Control Specialist at Zimmer Biomet (2015-01 – 2019-01)

• Coordinated document change control processes including issuance, review, approval routing, and archival of controlled documents.
• Reviewed and verified validation protocols and reports (IQ/OQ/PQ) to ensure procedural and regulatory compliance.
• Maintained document control systems ensuring only current revisions were available at point of use.
• Supported internal audits and compliance initiatives aligned with FDA quality system regulations.
• Ensured adherence to cGMP and Good Documentation Practices (GDP).

Bachelor of Science in Cardiovascular Technology – Pontifical Catholic University of Puerto Rico