Internal Auditor - job 1 of 2

As an Internal Auditor at ByHeart, you will oversee compliance with Good Manufacturing Practices (GMPs) and FDA regulations. Your responsibilities include conducting rigorous internal audits, preparing for third-party inspections, managing the cloud-based audit management system, and analyzing risks within our operational processes. You'll also support the development of programs and standard operating procedures to enhance our internal audit program.

To qualify for the Internal Auditor position at ByHeart, candidates should possess a Bachelor’s degree in a technical or life sciences field, along with 3-5 years of experience in a FDA regulated environment. Extensive knowledge of GMP regulations, experience in conducting internal audits, and strong analytical skills are also essential for this role.

ByHeart ensures compliance through a systematic approach, utilizing internal audits and regulatory inspections. The Internal Auditor plays a critical role in this process by examining the adherence to GMPs and reporting any issues while recommending corrective actions. This ongoing evaluation is essential in maintaining the high standards expected in our infant nutrition products.

The Internal Auditor at ByHeart is pivotal in upholding our commitment to quality and safety in infant nutrition. This role ensures that all processes meet the highest regulatory standards, which is fundamental to earning the trust of parents. By conducting thorough audits and ensuring compliance, you contribute significantly to our mission of providing the best infant formula available.

Working as an Internal Auditor at ByHeart means being part of a collaborative and dynamic team focused on innovation and quality. You will enjoy a supportive environment that values contributions and provides opportunities for professional growth. With competitive benefits like flexible time off and comprehensive health insurance, ByHeart emphasizes a family-first approach to work.

When responding to this question, detail your previous experiences with internal audits, including specific processes or systems you've evaluated. Highlight any compliance issues you've discovered and the corrective actions implemented, showcasing your critical thinking and problem-solving skills.

Provide examples of how you've applied FDA regulations and GMPs in your past roles. Discuss any specific regulations that pertain to food safety and how you've ensured compliance within your work environment.

Share a specific situation where you identified a compliance issue. Describe your process for investigating the matter, determining the root cause, and implementing solutions. Emphasize your ability to communicate effectively with stakeholders about the issue and its resolution.

Explain your approach to risk assessment, including any frameworks or methodologies you employ. Discuss how you gather data, involve team members in the process, and how this contributes to a thorough understanding of potential risks.

Discuss your methods for staying informed about changes in regulations, such as attending relevant workshops, subscribing to professional publications, or participating in industry networks. Show your commitment to lifelong learning in compliance and quality assurance.

Emphasize the need for clear, concise communication when dealing with audit findings, reporting, and recommendations. Discuss how effective communication can lead to better relationships with staff and a more compliant workplace.

Identify any specific audit management systems or software you’ve used in previous positions. Discuss how you've leveraged technology to enhance the efficiency and accuracy of your auditing processes.

Share your insights into the challenges industry auditors face, such as keeping up with regulatory changes, managing audit schedules, or addressing compliance issues swiftly. Discuss how you would approach these challenges if faced within your role at ByHeart.

Talk about your approach to addressing an unsatisfactory audit result, focusing on a structured approach for corrective action planning and re-evaluation. Demonstrate your commitment to resolved compliance and quality enhancement.

Express your passion for ensuring safety and quality in the food industry. Share personal anecdotes about how quality impacts consumer trust and how satisfying it is to play a role in improving products for families.