Quality Assurance Specialist I - GMP Night Shift

Alcami Corporation; Morrisville (NC); On-site; USD 52,000 - 76,000; Full time

Job summary

Alcami Corporation is seeking a Quality Specialist I to provide site quality support in a fast-paced environment, reviewing documents and data, and assisting with audits and inspections to ensure compliance with cGMP and regulatory requirements.

The role requires on-site presence with night shift on a 12-hour rotation (7:00pm–7:00am) and may involve developing or revising quality SOPs, training, and maintaining quality databases as needed.

Qualifications

• BS/BA/MS in a related field with 0–2+ years relevant experience or equivalent.
• AAS in a related field with 5+ years relevant experience or equivalent.
• Relevant GMP experience preferred.

Responsibilities

• Performs quality review of moderately complex documents, various types of data, protocols, and/or reports.
• Supports quality floor audits and/or floor inspections.
• Provides real-time on-the-floor review of documentation.
• 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.
• Assists with development or revisions to quality SOPs or other quality documents and/or reports as needed.
• Provides consultation on quality and compliance topics in areas of expertise.
• Provides training in quality and compliance topics in areas of expertise.

Skills

Quality review

Regulatory compliance

Documentation

SOPs

GMP knowledge

Data analysis

Team collaboration

Education

BS/BA/MS in related field

AAS in related field with 5+ years

Tools

ERP

EDMS

Microsoft Word

PowerPoint

Excel

Job description

Alcami Corporation is seeking a Quality Specialist I to provide site quality support in a fast-paced environment, reviewing documents and data, and assisting with audits and inspections to ensure compliance with cGMP and regulatory requirements.

The role requires on-site presence with night shift on a 12-hour rotation (7:00pm–7:00am) and may involve developing or revising quality SOPs, training, and maintaining quality databases as needed.