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Regulatory Compliance Auditor

2 months ago

Reading, Pennsylvania, United States ByHeart Full time

Company Overview
ByHeart is a pioneering infant nutrition organization dedicated to providing genuine innovation for babies and their parents. Our mission is straightforward: to produce the finest formula globally. We have meticulously researched the latest breast milk science, collaborated with trusted suppliers, established rigorous quality standards, developed a unique small batch blending process, and conducted a groundbreaking clinical trial. Our vision is to ensure that all parents feel confident about feeding their babies, regardless of the method they choose.

Role Overview
As a Quality Internal Auditor, you will play a crucial role in ensuring compliance with all Good Manufacturing Practices (GMPs), FDA regulations, and relevant state and federal laws applicable to our operations. You will report directly to the Regulatory Compliance Manager and work collaboratively with various teams to uphold our commitment to quality.

Key Responsibilities

  • Ensure that quality systems, processes, and GMP-related activities are compliant with established standards.
  • Conduct systematic audits, present findings, and recommend necessary procedural changes to address compliance issues.
  • Support inspection readiness for third-party and regulatory audits, providing assistance during these evaluations.
  • Contribute to the development of programs, workflows, and standard operating procedures for the Internal Audit program.
  • Manage the cloud-based audit management system effectively.
  • Schedule and execute internal audits to assess compliance.
  • Assist in managing the Supplier Qualification Program, including documentation and risk assessments.
  • Prepare and review audit reports, ensuring clarity and accuracy.
  • Analyze potential risks within the facility to prevent compliance issues.
  • Monitor the progress of audit findings and report updates to management.
  • Ensure timely completion of commitments arising from regulatory inspections and audits.
  • Assist in completing departmental Change Controls, CAPAs, and Deviations as required.
  • Review internal responses to audit findings to determine acceptability and follow up on corrective actions.
  • Support additional Quality Assurance and Regulatory Compliance tasks as needed.
Qualifications
  • Bachelor's degree in a relevant technical or life sciences field; equivalent experience may be considered.
  • 3-5 years of relevant experience, particularly in an FDA-regulated environment.
  • Extensive experience in conducting internal audits.
  • Familiarity with regulatory authorities is preferred.
  • Strong knowledge of applicable GMP regulations and guidelines.
  • Ability to analyze data logically and draw appropriate conclusions.
  • Understanding of company operations and practices.
  • Excellent technical writing skills to convey findings and recommendations clearly.
  • Advanced written and oral communication skills.
  • Ability to build effective relationships with various levels of staff.
  • Strong analytical skills to evaluate processes and identify risks.
  • Meticulous attention to detail.
Benefits
We offer a comprehensive benefits package, including health insurance, flexible paid time off, parental leave, 401(k) matching, and company equity for all employees. We are committed to fostering an inclusive workplace and welcome all qualified applicants to apply.