Quality Specialist II - GMP & Audits (Night Shift)

Alcami Corporation; Morrisville (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

Alcami Corporation is seeking a Quality Specialist II to provide on-site quality support across GMP-regulated environments. The role includes document review, data analysis, and contributing to audits and inspections. You will help maintain quality databases, support investigations, and assist with SOP development and training.

Qualifications include a related degree with 2–7+ years of experience or an A.A.S. with 10+ years, plus GMP familiarity. On-site, night shift expectations apply.

Qualifications

• B.S./B.A./M.S. in a related field with 2–7+ years relevant experience or equivalent.
• A.A.S. in a related field with 10+ years relevant experience or equivalent.
• Relevant GMP experience preferred.

Responsibilities

• Performs quality review of complex documents, various types of data, protocols, and/or reports.
• Supports quality floor audits and/or floor inspections.
• Supports client and regulatory agency audits and inspections, as needed.
• Maintains quality databases and may perform analysis and trending.
• Assists with quality improvement initiatives as needed.
• Identifies and reports issues in a timely manner.
• Develops quality SOPs or other quality documents and/or reports as needed.
• Provides consultation on complex quality and compliance topics in areas of expertise.
• Develops and provides training in quality and compliance topics in areas of expertise.

Skills

Quality systems

Document reviews

Audit support

Problem solving

Communication

Education

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

A.A.S. in related field

Tools

ERP

EDMS

Microsoft Word

PowerPoint

Excel

Job description

Alcami Corporation is seeking a Quality Specialist II to provide on-site quality support across GMP-regulated environments. The role includes document review, data analysis, and contributing to audits and inspections. You will help maintain quality databases, support investigations, and assist with SOP development and training.

Qualifications include a related degree with 2–7+ years of experience or an A.A.S. with 10+ years, plus GMP familiarity. On-site, night shift expectations apply.