Client-Audit Quality Specialist II (On-Site)

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

Job summary

Alcami Corporation in Morrisville, NC is seeking a Quality Specialist II on the Audit Team. This on-site role drives quality and regulatory compliance in a fast-paced environment, reviewing documents, supporting audits, and developing SOPs.

The successful candidate will serve as SME during client audits, draft responses to observations, track CAPA effectiveness in EDMS, and help create routine management reviews of audit trends to drive continuous improvement.

Qualifications

• Bachelor's/Master's degree in a related field with 2–7+ years of experience or equivalent.
• A.A.S. in a related field with 10+ years of experience or equivalent.
• Relevant GMP experience preferred.

Responsibilities

• Performs quality review of complex documents, 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 at all levels.
• Provides training on quality and compliance topics in areas of expertise.
• Understands Quality Management Systems including Investigations, CAPA, Change Control, etc.
• Mentor staff within the Compliance team.

Skills

Quality Assurance

Auditing

Regulatory Compliance

Documentation Review

SOP Development

Training & Mentoring

Problem Solving

Attention to Detail

Communication

GMP

Education

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

A.A.S. in related field

Tools

EDMS

CAPA tracking

Microsoft Office

Job description

Alcami Corporation in Morrisville, NC is seeking a Quality Specialist II on the Audit Team. This on-site role drives quality and regulatory compliance in a fast-paced environment, reviewing documents, supporting audits, and developing SOPs.

The successful candidate will serve as SME during client audits, draft responses to observations, track CAPA effectiveness in EDMS, and help create routine management reviews of audit trends to drive continuous improvement.