Role Description

Reports To: Regulatory Compliance Manager

Location: ByHeart Facility (Allerton, Iowa)

Start Date: ASAP

The Quality Internal Auditor is responsible for ensuring the company is adhering to all GMPs, FDA Regulations and Guidelines, state, federal, and local laws applicable to the business.

Role Responsibilities

• Responsible for ensuring quality systems, processes, and good manufacturing practices related activities are within compliance.
• Executes a systematic approach to conducting audits, presenting the findings, and recommending changes to procedures or practices that are not in compliance. Providing technical assistance to implement a plan to address such changes, as needed.
• Assist with inspection readiness activities for third party and regulatory audits. Provides support during third party and regulatory audits.
• Assist with the development of programs, workflows, and standard operating procedures for the Internal Audit program.
• Management of cloud-based audit management system.
• Schedules and conducts internal audits.
• Assist in managing and maintaining the Supplier qualification program, including TraceGains systems, associated documentation, approved supplier list, and risk assessments.
• Assists in preparing and reviewing audit reports.
• Analyze potential risks within the facility in order to avoid compliance issues.
• Responsible for reviewing progress toward closure of audit findings and reporting the progress to appropriate management weekly and monthly. Performs follow-up on all supplied information in order to perform verification checks on proposed corrective actions and CAPAs.
• Ensures timely completion of commitments from regulatory agency inspections and partner audits related to audit programs.
• Assists in completing department related Change Controls, CAPAs and Deviations, as needed.
• Reviews and evaluates Internal responses to determine acceptability of the response and any applicable CAPA plans. Performs follow up activity to ensure effective CAPA implementation that resolves and documents issues pertaining to the internal, third party and regulatory audits.
• Assist in additional Quality Assurance and Regulatory Compliance jobs as needed.

Skills & Qualifications

• Bachelor's degree in related professional technical or life sciences degree. Substitution of experience may be accepted.
• 3-5 years of related experience, must include knowledge of an FDA regulated environment.
• Extensive experience in conducting internal audits.
• Experience in dealing with regulatory authorities desired.
• Strong knowledge of all applicable Good Manufacturing Practice regulations and guidelines.
• Ability to reason logically, analyze and evaluate data and information, and draw appropriate conclusions.
• Understanding of the company operations and practices.
• Demonstrated technical writing skills with the ability to write clearly and concisely conveying the information precisely to the findings and recommendations required.
• Advanced level of written and oral communication skills with the ability to obtain, clarify, or give factual information, interpret instructions, and record data.
• Ability to build and maintain effective business partner relationships with varied levels of staff.
• Active listening skills demonstrating the ability to give full attention to what others are saying, understanding the points being made, and asking the appropriate questions during the audit process.
• Demonstrated analytical and interpretive skills with the ability to examine processes, identify assumptions, and gather details accurately.
• Ability to understand levels of potential risks and how to address those risks.
• Strong attention to detail.
• Ability to study/review complicated things and explain them.

This role is eligible for relocation support for candidates requiring a move to Allerton, IA. Additionally, you will be eligible for a discretionary performance based annual cash bonus and to participate in our company's equity program, plus our robust medical, dental, vision, retirement, and other benefits.