Quality Assurance Auditor

Keystone Distinction Group; Lancaster (SC); On-site; USD 90,000 - 120,000; Full time

Job summary

Keystone Distinction Group seeks a QA Inspector to build and sustain a robust Internal Compliance program. You will perform internal and external audits, manage vendor qualifications, and drive corrective actions in a regulated environment.

Responsibilities include audit planning, risk assessment, and training across departments to meet Quality Assurance expectations and regulatory inspection readiness. Travel up to 20–30% may be required.

Qualifications

• Minimum 5 years QA auditing in a cGMP environment.
• Experience with external vendor/supplier audits in FDA-regulated industries.
• Knowledge of 21 CFR Part 210, 211, 507 and 21 CFR 111 dietary supplement regs.

Responsibilities

• Plan, schedule, and conduct internal and external audits.
• Audit suppliers and manage vendor qualification.
• Manage supplier corrective action requests and documents.
• Assess risk of findings and track corrective actions.
• Develop performance tracking and reporting for compliance.
• Train internal departments on Quality and Compliance expectations.
• Support regulatory inspections readiness.

Skills

Quality Assurance auditing

cGMP knowledge

FDA regulations

ASQ CQA (preferred)

MS Office proficiency

Education

B.A. or B.S. in Science/Technical field

Tools

MS Office

Job description

Summary of the Position

This role is responsible for developing and maintaining a strong Internal Compliance program ensuring compliance to applicable regulations. The QA Inspector is required to perform internal and external audits, prioritize audit schedules and corrective actions to the findings identified.

Roles and Responsibilities

• Manage audit planning, scheduling, and execute internal and external audits to assess compliance to the regulations.
• Audit external suppliers and maintain the vendor qualification program.
• Manage external vendor responsible for international audits
• Manage supplier corrective action request program.
• Manage all documents relating to audits, vendors, and suppliers.
• Determine the level of risk of findings identified and follow up on corrective actions ensuring they address the short-term correction as well as the preventive action of the finding.
• Develop and implement a performance tracking system and reporting of departmental compliance.
• Prioritize work to ensure that audits and reports are completed in a timely manner. Support implementation of programs where necessary.
• Train and assist internal departments to understand and comply with Quality and Compliance expectations.
• Assess internal audit process by identifying and prioritizing areas of the business where there is a risk of non-compliance and assist in development and/or execute processes or policies to reduce that risk.
• Support training and readiness for regulatory inspections.
• Provide support to other Quality Assurance team members.
• Report audit metrics to Quality Assurance and department management.
• Communicate effectively with all levels of the organization and departments within the organization and function within a team environment.
• Understand the roles and responsibilities of the Contract Manufacturing Organizations and provide Quality Assurance support for product development, and investigations, as required.
• Perform other assigned duties as may be required in meeting Quality Assurance and company objectives.

Requirements

• Must have a minimum of 5 years of Quality Assurance auditing experience in cGMP environment with a minimum of 5 years of external vendor/ supplier compliance auditing experience within an FDA regulated industry.
• Knowledge of the Regulations 21CFR Part(s) 210, 211, 507 as well as the Dietary Supplement Regulations 21 CFR 111 is required.
• ASQ Certified Auditor (CQA) Certification is preferred.
• Must be proficient in Computer Software applications including MS office suite.
• Must be able to stand, walk, push, and pull in a variety of environments including a Manufacturing and clean rooms.
• Must have the ability to wear all required Personal Protective Equipment (PPE) based on the auditing environment.
• Must be able to travel 20 – 30% for audits.

Education and Experience

• B.A. or B.S. in Science or Technical field required.