Quality Assurance Auditor

Astrix; Charleston (SC); On-site; USD 70,000 - 95,000; Full time

Job summary

Astrix in the Charlotte metro area is seeking a Quality Assurance Auditor to join our team. This role involves leading audit planning, internal and external audits, and ensuring compliance with cGMP and FDA regulations to support high-quality nutraceutical products.

The ideal candidate has a Bachelor's degree in a scientific field, 5 years of QA auditing experience in an FDA-regulated setting, and willingness to travel to supplier sites on short notice.

Qualifications

• Bachelor’s degree in a scientific field.
• 5 years of QA auditing experience in a cGMP environment & external vendor/supplier compliance within an FDA regulated industry.
• Knowledge of Regulations 21 CFR Part 210, 211, 507 as the dietary supplements regulations 21 CFR.
• Experience with internal & external auditing.

Responsibilities

• Manage audit planning, scheduling, and execute internal and external audits.
• Maintain the vendor qualification program including the Approved Vendor List and supplier corrective action request program (SCAR).
• Manage external vendor(s) responsible for international audits.
• Manage all documents relating to audits, vendors, and suppliers in a QMS.
• Determine the level of risk of findings identified and follow up on corrective actions.
• Develop and implement a performance tracking system and reporting of departmental compliance.
• Train and assist internal departments to understand and comply with Quality and Compliance expectations.

Skills

Auditing

Vendor management

Regulatory knowledge

Travel readiness

Education

Bachelor's degree in a scientific field

Tools

QMS systems

Job description

Pay Rate Low: 70000 | Pay Rate High: 95000

If you are seeking an opportunity in a Nutraceutical lab that will offer the opportunity to grow this is the position for you! We are seeking a Quality Assurance Auditor to join our team. This is a great opportunity to work with a team that takes pride in producing high quality products that support their consumers overall health. Schedule: 1st shift

Location : Charlotte Metro area

Responsibilities

• Manage audit planning, scheduling, and execute internal and external audits
• Maintain the vendor qualification program including the Approved Vendor List and supplier corrective action request program (SCAR)
• Manage external vendor(s) responsible for international audits
• Manage all documents relating to audits, vendors, and suppliers in a QMS
• Determine the level of risk of findings identified and follow up on corrective actions
• Develop and implement a performance tracking system and reporting of departmental compliance.
• Train and assist internal departments to understand and comply with Quality and Compliance expectations.

Requirements

• Bachelor’s degree in a scientific field
• 5 years of QA auditing experience in a cGMP environment & external vendor/supplier compliance within an FDA regulated industry.
• Knowledge of Regulations 21CFR Par(s) 210, 211, 507 as the dietary supplements regulations 21 CFR
• Must have experience with internal & external auditing.
• Must have the flexibility to travel to suppliers for audits with limited notice.