GMP Quality Assurance Lead — Night Shift

Alcami-5; Morrisville (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Alcami is seeking a Senior Quality Assurance Specialist to drive GMP-compliant quality programs in a fast-paced environment. You will review documents, perform audits, host inspections, and guide SOP development while mentoring Operations to achieve regulatory readiness.

On-site only, night shift rotating 12 hours (7:00pm–7:00am) may be required, with occasional travel to support other Alcami sites. The role emphasizes collaboration across departments and maintaining quality databases.

Qualifications

• Bachelor’s degree in Chemistry, Biology, or related field with 5-7+ years of GMP related experience, or Master’s degree in related field.
• Experience performing GMP document creation and issuance (batch records, logbooks, forms).
• Knowledge of aseptic parenteral manufacturing and GMP Annex 1 is preferred.

Responsibilities

• Performs quality review and approval of documents, data, protocols, and/or reports.
• Performs GMP document creation and issuance (batch records, logbooks, forms).
• Performs internal quality audits and/or inspections.
• Supports client audits and regulatory inspections.
• Maintains quality databases and supports quality systems.

Skills

GMP knowledge

Quality assurance

Auditing

Regulatory compliance

Education

Bachelor’s degree in Chemistry, Biology, or related field

Tools

Quality databases

Document management systems

Auditing tools

Job description

Alcami is seeking a Senior Quality Assurance Specialist to drive GMP-compliant quality programs in a fast-paced environment. You will review documents, perform audits, host inspections, and guide SOP development while mentoring Operations to achieve regulatory readiness.

On-site only, night shift rotating 12 hours (7:00pm–7:00am) may be required, with occasional travel to support other Alcami sites. The role emphasizes collaboration across departments and maintaining quality databases.