Internal Auditor

1 month ago

Reading, United States ByHeart Full time

ByHeart is an infant nutrition company built from the ground up to deliver real innovation on behalf of babies and parents. Our mission is simple: make the best formula in the world. That's why we studied the latest breast milk science, worked directly with suppliers we know and trust, set uncompromising quality standards, developed our own small batch blending process, built our own manufacturing facilities, and conducted a groundbreaking clinical trial. Our goal is to create a future where all parents feel amazing about feeding their baby-no matter how they do it.

When we launched our Whole Nutrition Infant Formula in March 2022, we were the first new U.S infant formula manufacturer in 15 years. Since then, we've been leading the way in a lot of ways.

We're...

  • The only U.S.-made infant formula to use organic, grass-fed whole milk
  • The first and only U.S. infant formula company to add the two most abundant proteins found in breast milk-alpha-lac and lactoferrin-to our ingredients list
  • The first infant formula company to receive Clean Label Project's Purity Award (and we test for 700 contaminants vs the required 400)
  • We ran the largest clinical trial by a new infant formula brand in 25 years-clinically proving our benefits vs a leading infant formula like:
    • Less spit up
    • Softer poops
    • Easier digestion
    • More efficient weight gain
    • Enhanced nutrient absorption
    • Longer stretches between nighttime feeds*
With >$250M in funding, we're shifting the industry forward-and this is just the beginning. Help us build a future where all parents can feel amazing about feeding, by joining our growing team of >275 people that stretches across the country.

We're proud to offer competitive, family-first benefits, including but not limited to:
  1. Health insurance for the whole family: medical, dental, & vision insurance covered 100%, with 90% coverage for your family.
  2. Flexible paid time off: plus 12+ company holidays, and 2 floating holidays to use at your discretion
  3. 16-weeks of fully-paid parental leave and new parent support: free 1-year supply of formula, cozy feeding suites, and paid pumping time.
  4. Up to 6% 401(k) Match to help you plan for your future.
  5. Company equity for every employee: because when we succeed, we succeed together

Visit our site to learn more, and check out some recent press on ByHeart:
  • White House Roundtable:President Biden Meets with Infant Formula Manufacturers
  • Business Insider: ByHeart Announces Published Data in a Scholarly Journal on Benefits of The Novel High Quality Protein Blend in Their Groundbreaking Next-Generation Easy to Digest Infant Formula
  • Governor Wolf Press Conference: Gov. Wolf highlights state investment in ByHeart, first new formula manufacturer in 15 years
  • CBS News: As parents scramble to find baby formula, a new manufacturer is seeing soaring demand
  • Forbes: A Startup Wanted To Make A Better Baby Formula. It Took Five Long Years.
*based on data from infants at approximately 4 months of age

Role Description

Reports To: Regulatory Compliance Manager

Location: ByHeart Facility (Reading, PA)

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.

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.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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