Quality Audit Specialist II: Compliance & CAPA Lead

Alcami Corporation; Durham (NC); On-site; USD 70,000 - 95,000; Full time

Job summary

Alcami Corporation in Durham, NC is seeking a Quality Specialist II to join the Audit Team. This role centers on driving quality and regulatory compliance, supporting client audits, maintaining databases, and developing SOPs.

You will partner with audit hosts, respond to real-time Q&A, draft responses to observations, and help drive continuous improvement across sites. 100% on-site with up to 10% travel.

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 all levels of regulatory issues.
• Provides consultation on complex quality and compliance topics in areas of expertise.
• Develops and provides training in quality and compliance topics in areas of expertise.
• Understands Quality Management Systems including Investigations, Corrective Actions, Change Control, etc.
• Serve as an effective member of the Compliance team and serve as a mentor in area of expertise.
• Comply with company policies and SOPs.
• Assist with quality improvement initiatives as needed.
• Ensure timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

Skills

Regulatory knowledge

Audit leadership

Documentation & SOPs

MS Office

Mentoring

Communication

Problem solving

Attention to detail

Negotiation

Audit facilitation

Education

B.S./B.A./M.S. in a related field

A.A.S. in a related field

Tools

EDMS

Microsoft Office

Job description

Alcami Corporation in Durham, NC is seeking a Quality Specialist II to join the Audit Team. This role centers on driving quality and regulatory compliance, supporting client audits, maintaining databases, and developing SOPs.

You will partner with audit hosts, respond to real-time Q&A, draft responses to observations, and help drive continuous improvement across sites. 100% on-site with up to 10% travel.