GMP Quality Audit Specialist II

Alcami Corporation; Durham (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Alcami Corporation in Durham, NC is seeking a Quality Specialist II - Audit Team to drive quality and regulatory compliance by reviewing documents, supporting audits and inspections, and developing SOPs and quality materials.

In this on-site role, you will partner with audit hosts, act as SME during client audits, draft responses to observations, manage CAPAs in EDMS, and mentor other compliance staff while advancing continuous improvement initiatives.

Qualifications

• B.S./B.A./M.S. in a related field with 2–7+ years relevant experience or equivalent.
• A.A.S. in a related field with 10+ years relevant experience or equivalent.
• Relevant GMP experience preferred.

Responsibilities

• Performs quality review of complex documents, all types of data, protocols, and/or reports.
• Supports quality floor audits and/or floor inspections.
• Supports client and regulatory agency audits and inspections, as needed.
• Seeks to understand customer needs. Advocates for the client within the business unit.
• Identifies deficiencies that require action and supports customer decision making.
• Serves as SME in client audits, audit tours, and audit response.
• Maintains quality databases and may perform analysis and trending.
• Assists with quality improvement initiatives as needed.
• Consult with clients on regulatory issues. Provides consultation on complex quality topics.
• Develops and provides training in quality topics.

Skills

Audit leadership

Quality documentation

Regulatory knowledge

Communication skills

Mentoring

Education

BS/BA/MS in related field

AS in related field with 10+ years experience

Job description

Alcami Corporation in Durham, NC is seeking a Quality Specialist II - Audit Team to drive quality and regulatory compliance by reviewing documents, supporting audits and inspections, and developing SOPs and quality materials.

In this on-site role, you will partner with audit hosts, act as SME during client audits, draft responses to observations, manage CAPAs in EDMS, and mentor other compliance staff while advancing continuous improvement initiatives.