QA Specialist I, Night Shift — GMP Compliance

Alcami-5; Morrisville (NC); Presencial; USD 54.000 - 76.000; Jornada completa

Descripción de la vacante

Alcami, a leading provider of transformative medicines, seeks a Quality Specialist I to support site quality in a fast-paced environment. You will review documents, assist with audits, maintain databases, and contribute to Quality Management Systems while ensuring cGMP compliance.

This on-site role involves collaboration with cross-functional teams and occasional travel. Role emphasizes accuracy, attention to detail, and proactive quality improvements.

Formación

• B.S./B.A./M.S. in a related field with 0–2+ years relevant experience or equivalent.
• A.A.S. in a related field with 5+ years relevant experience or equivalent.
• Relevant GMP experience preferred.

Responsabilidades

• Performs quality review of moderately complex documents, data, protocols, and reports.
• Supports quality floor audits and/or floor inspections.
• Provides on-the-floor review of documentation in real time.
• Supports client and regulatory agency audits and inspections as needed.
• Maintains quality databases and may perform analysis and trending.
• Assists with development or revisions to quality SOPs or other quality documents.

Conocimientos

GMP knowledge

Documentation skills

Regulatory compliance

Attention to detail

Communication skills

Educación

B.S./B.A./M.S. in related field

A.A.S. in related field

Herramientas

ERP

EDMS

MS Word

PowerPoint

Excel

Descripción del empleo

Alcami, a leading provider of transformative medicines, seeks a Quality Specialist I to support site quality in a fast-paced environment. You will review documents, assist with audits, maintain databases, and contribute to Quality Management Systems while ensuring cGMP compliance.

This on-site role involves collaboration with cross-functional teams and occasional travel. Role emphasizes accuracy, attention to detail, and proactive quality improvements.