Quality Assurance Auditor

H. T. PROF Group; Lancaster (SC); On-site; USD 65,000 - 90,000; Full time

Job summary

H. T. PROF Group is seeking an experienced QA Auditor to develop and maintain a strong internal compliance program. You will conduct internal and external audits, manage vendor qualification, and drive corrective actions while ensuring regulatory readiness.

Responsibilities include planning audits, evaluating risk, maintaining documentation, and training teams on quality and compliance in a manufacturing environment. Travel up to 30% may be required.

Qualifications

• Minimum 5 years of QA auditing in a cGMP environment with external vendor/supplier auditing experience.
• Knowledge of 21 CFR Part 210, 211, 507 and 21 CFR 111 (DS).
• ASQ Certified Auditor (CQA) preferred.
• Proficient in MS Office applications.
• Ability to stand, walk, push and pull in manufacturing and clean room environments.
• Willingness to wear PPE as required during audits.
• Travel 20–30% for audits.

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 all documents relating to audits, vendors, and suppliers.
• 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.
• Prioritize work to ensure audits and reports are completed in a timely manner.
• 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 with risk of non-compliance.
• 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 in a team environment.
• Understand CMO roles and provide QA support for product development and investigations.
• Perform other assigned duties to meet QA and company objectives.

Skills

Audit planning

Compliance auditing

Vendor auditing

cGMP

FDA compliance

Education

Bachelor's degree in Science/Technical field

Tools

MS Office

Job description

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 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.