Quality Audit Specialist II - On-Site, 1st Shift

Alcami-5; Morrisville (NC); On-site; USD 75,000 - 110,000; Full time

Job summary

Alcami is seeking a Quality Specialist II - Audit Team to drive quality and regulatory compliance in a fast-paced, on-site environment. You will review complex documents, support client and regulatory audits, and act as a SME on audit responses and CAPA effectiveness across sites.

The role involves developing training, mentoring other compliance staff, and maintaining quality databases. Occasional travel and adherence to cGMP training are required.

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 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.

Skills

Regulatory knowledge

Quality Systems

GMP

Documentation

Audit leadership

Communication skills

Mentoring

Problem-solving

Detail-oriented

Training

Education

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

A.A.S. in related field

GMP experience preferred

Tools

Microsoft Office

Job description

Alcami is seeking a Quality Specialist II - Audit Team to drive quality and regulatory compliance in a fast-paced, on-site environment. You will review complex documents, support client and regulatory audits, and act as a SME on audit responses and CAPA effectiveness across sites.

The role involves developing training, mentoring other compliance staff, and maintaining quality databases. Occasional travel and adherence to cGMP training are required.