Compliance Analyst (Temporary Assignment)

About the role

The Compliance Analyst will support the Quality System by conducting special audits, monitoring lot documentation, and ensuring adherence to regulatory requirements for medical device and pharmaceutical products. This temporary assignment involves close collaboration with Manufacturing, QA, and supply chain teams to resolve non‑conformances and drive continuous improvement.

Key responsibilities

• Perform spot screenings of lot documents and routine in‑process monitoring audits.
• Generate and manage Non‑Conformance Reports (NCRs) for raw material and product deviations.
• Lead investigations, root‑cause analysis, and corrective/preventive actions (CAPA) to close NCRs.
• Monitor and report quality KPIs, develop actions to improve metrics, and support QI initiatives.
• Conduct compliance inspections and assist with batch release for dry‑process products.

Required profile

• Minimum five years of experience in a medical‑device or pharmaceutical quality/compliance role.
• Bilingual communication skills in English and Spanish.
• Strong analytical ability, self‑motivation, and service‑oriented attitude.
• Ability to work in an office environment, stand, walk, and travel as needed.

Required skills

• Knowledge of GMP and QSR regulations.
• Proficiency with Microsoft Word, Excel, and PowerPoint.