Senior Quality Assurance Specialist - Night Shift (GMP)

NCBioImpact; Morrisville (NC); On-site; USD 90,000 - 115,000; Full time

Job summary

Alcami is seeking a Quality Senior Specialist for a 12-Hour Night Shift (2-2-3) in Morrisville, NC. You will support site quality, review complex documents, and help ensure GMP compliance across laboratories and manufacturing facilities.

100% on-site, night schedule, and engagement with audits and training. The role emphasizes quality databases, trend analysis, and the creation of SOPs, with guidance to escalate issues and drive continuous improvement.

Qualifications

• B.S./B.A./M.S. in a related field with 8-12+ years relevant experience or equivalent.
• A.A.S. in a related field with 15+ years relevant experience or equivalent.
• Relevant GMP experience preferred.

Responsibilities

• Performs quality review of complex documents, all 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.
• Seeks to understand customer needs. Advocates for the client within the business unit.
• Identifies deficiencies that require action and supports customer decision making.
• 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.

Education

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

A.A.S. in a related field

Tools

ERP

EDMS

Microsoft Word

PowerPoint

Excel

Job description

Alcami is seeking a Quality Senior Specialist for a 12-Hour Night Shift (2-2-3) in Morrisville, NC. You will support site quality, review complex documents, and help ensure GMP compliance across laboratories and manufacturing facilities.

100% on-site, night schedule, and engagement with audits and training. The role emphasizes quality databases, trend analysis, and the creation of SOPs, with guidance to escalate issues and drive continuous improvement.