Senior Quality Specialist, GMP & Compliance

Alcami; Morrisville (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Alcami is seeking a Quality Senior Specialist to provide site quality support in a fast-paced environment, reviewing complex documents and supporting audits to ensure GMP compliance. The role develops SOPs and trains teams, operating with independence under defined procedures.

The on-site night shift (12-hour rotations) and travel up to 5% are part of the role. Strong GMP knowledge and experience with ERP, EDMS, and MS Office are required.

Qualifications

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

Responsibilities

• Performs quality review of complex documents, data, and reports.
• Supports audits and inspections at facility.
• Maintains quality databases and may perform trend analysis.
• Develops quality SOPs or reports as needed.
• Provides consultation on complex quality topics.
• Trains others in quality and compliance topics.

Skills

Quality knowledge

Regulatory compliance

GMP experience

Document review

Training others

Data analysis

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 is seeking a Quality Senior Specialist to provide site quality support in a fast-paced environment, reviewing complex documents and supporting audits to ensure GMP compliance. The role develops SOPs and trains teams, operating with independence under defined procedures.

The on-site night shift (12-hour rotations) and travel up to 5% are part of the role. Strong GMP knowledge and experience with ERP, EDMS, and MS Office are required.