Night-Shift Quality & Compliance Specialist

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

Job summary

Alcami Corporation is seeking a Quality Specialist for a 12-hour night shift in Morrisville, NC. The role ensures quality and regulatory compliance across site activities, reviews complex documents, supports audits, and maintains quality databases while contributing to SOP development and training.

The position requires GMP experience and a Bachelor’s or Master’s degree in a relevant field with several years of related work. On-site duties and 2-2-3 night schedule apply.

Qualifications

• Bachelor's degree in Chemistry, Biology, or relevant field with 3+ years of related experience; or a Master’s with 1+ years of related experience.
• GMP experience is required for this role.
• Experience in Environmental monitoring and critical utilities is preferred for sterile operations.

Responsibilities

• Support manufacturing processes on the floor.
• Performs quality review and approval of complex documents, data, protocols, and/or reports.
• Supports quality floor audits and/or floor inspections.
• Supports for client and regulatory agency audits and inspections.
• Provides quality evaluation and release of support materials, products, equipment and facilities as required.
• Maintains quality databases and may perform analysis and trending.
• Assists with quality improvement initiatives as needed.
• Develops quality SOPs or other quality documents and/or reports as needed.

Skills

GMP experience

Environmental monitoring

Regulatory compliance

Education

Bachelor's degree in Chemistry, Biology, or relevant field

Master's degree in relevant field

Tools

Microsoft Office

Job description

Alcami Corporation is seeking a Quality Specialist for a 12-hour night shift in Morrisville, NC. The role ensures quality and regulatory compliance across site activities, reviews complex documents, supports audits, and maintains quality databases while contributing to SOP development and training.

The position requires GMP experience and a Bachelor’s or Master’s degree in a relevant field with several years of related work. On-site duties and 2-2-3 night schedule apply.