Quality Audit Specialist II | Client & Regulatory Expert

Alcami Corporation; Durham (NC); Hybrid; USD 70,000 - 100,000; Full time

Job summary

Alcami Corporation seeks a Quality Specialist II - Audit Team to drive quality and regulatory compliance across audits and inspections. The role handles complex document reviews, CAPA responses, and EDMS submissions while mentoring teammates.

You will partner with audit hosts, support tours, and lead routine management reviews of audit trends to foster continuous improvement. On-site, with travel up to 10% for audits.

Qualifications

• BS/BA/MS in a related field or equivalent with 2–7+ years of experience.
• AS in a related field with 10+ years of experience or equivalent.
• GMP experience preferred.

Responsibilities

• Performs quality review of complex documents, data, protocols, and reports.
• Supports client and regulatory audits and inspections as needed.
• Develops responses to observations and CAPA effectiveness tracking.
• Mentors other compliance staff and shares subject-matter expertise.
• Maintains quality databases and conducts trend analysis when required.
• Ensures compliance with cGMP and SOPs across sites.

Skills

Audit readiness

Regulatory knowledge

Documentation skills

Communication

Mentoring

Education

Bachelor's/Master's in related field

AS in related field with experience

Tools

EDMS

Microsoft Office

Quality databases

Job description

Alcami Corporation seeks a Quality Specialist II - Audit Team to drive quality and regulatory compliance across audits and inspections. The role handles complex document reviews, CAPA responses, and EDMS submissions while mentoring teammates.

You will partner with audit hosts, support tours, and lead routine management reviews of audit trends to foster continuous improvement. On-site, with travel up to 10% for audits.