Quality Assurance Specialist

Position : Quality Assurance Specialist

Location : Charleston, SC

Shift : 2nd Shift | Monday – Friday | 3 : 00 PM – 11 : 00 PM

Compensation : $65,000 – $85,000

Benefits : Full Benefits Package | Paid Time Off | 401(k) | Relocation Assistance Available

Overview

We are seeking a detail-oriented and experienced Quality Assurance Specialist to join our team in a sterile manufacturing environment. This role is critical to ensuring compliance with cGMP standards and maintaining the highest levels of product quality and data integrity. The ideal candidate will have hands-on experience in sterile manufacturing, environmental monitoring, and quality documentation processes.

Key Responsibilities

• Perform quality review and approval of deviations, investigations, batch records, protocols, and reports.
• Conduct floor audits and inspections to ensure compliance with GDP and data integrity standards.
• Support client and regulatory audits, providing documentation and insight as needed.
• Oversee the release of support materials, products, equipment, and facilities.
• Maintain and analyze quality databases; identify trends and improvement opportunities.
• Develop and revise SOPs and other quality documentation.
• Provide training and consultation on quality and compliance topics.
• Ensure timely and accurate completion of all cGMP and company training requirements.
• Actively contribute to the site’s Quality Management Systems (QMS), including investigations, CAPAs, and change controls.

Qualifications

Skills & Competencies

Work Environment & Physical Demands