Quality Assurance Operations Manager

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

Location: Allerton, Iowa

Start Date: ASAP

Role Responsibilities

• Quality Assurance Manager leads a team of individuals to ensure compliance to Infant formula standards. regulations, FSMA, Certifications (not limited to: GFSI, Organic, Kosher) and Internal Quality/Food Safety Programs and Policies. Provides leadership within the facility to drive positive change through influence and example. Considered main quality liaison with Production.
• Responsible to ensure plant compliance with the Food Safety and Quality Plans along with supporting prerequisite programs. Manages quality operations activities to help ensure compliance with all applicable state, federal regulations, and international standards for the manufacture of Food and Infant Formula products. Through cross functional teamwork with Production maintains an effective plant hygiene plan and cGMP environment.
• Responsible for the day-to-day operations of the laboratory and ensuring good laboratory practices are implemented, documented, and sustained. Conducts oversight management for any testing that is outsourced.
• Oversees supplier approval program and the Chemical review/approval program for the site. Actively supports and participates in the internal audit program. Performs the material / product lot release process and participates/supports as requested regulatory inspections (e.g. PDA) and / or third-party audits / certifications (e.g. SQF, Kosher, Organic)
• Participates/supports investigations relating to non-conforming events (including product complaints) driving to root cause(s) and effective resolution (corrective actions).
• Monitors compliance to customer expectation and specifications, communicates any issues/concerns and maintains audit readiness / preparedness for customers, regulatory agencies, and visitors/contractors.
• Assists / supports in the execution of validation processes and improvement projects.
• Assists / supports facility’s management of the change control program to enable robust risk assessment and decisions.
• Tracks and reports on plant quality key metrics and trends & prepares / issues Monthly Quality reports to management on an ongoing basis to ensure transparency.
• Participates in training for plant personnel and visitors/contractors concerning food safety, FSMA and cGMPs.
• Provides support to quality leadership during unplanned events or emergencies.

Skills & Qualifications

• Infant Formula or Food (Dairy) manufacturing experience preferred.
• Knowledge of principles and practices of supervision, training, and personnel management.
• Accuracy and thoroughness in completion of duties is crucial to success
• Able to organize and prioritize resources to achieve goals
• Able to multi-task; able to keep organized records; able to work with accuracy and attention to detail.
• Able to perform analysis, mathematical calculations, and statistical evaluations.
• Able to communicate clearly and effectively, both verbally and in writing.
• Able to work in collaboration effectively, foster good teamwork and promote a team environment
• Able to present options and ideas to current processes or procedures and is solution minded.
• Able to handle challenging or conflict situations with tact and professionalism.
• Able to adapt and manage to change effectively.
• Able to take initiative in performing job.
• Able to perform task and duties without constant supervision.
• Background in overseeing laboratory facilities and equipment experience.

• Bachelor's degree required in Food Science, Biological Sciences or related field
• Working knowledge of 21 CFR Part 106, 107, & 117. 1-3 years of supervisory experience. 2-5 years of experience in food processing environment (Ideally Dairy and a plus if Infant Formula).
• SQF Practitioner certified or obtained within first 90 days.

Physical Requirements

• Ability to lift up to 40 lb (e.g. quality samples, files and supplies).
• Job involves approximately 60% walking/standing and 40% sitting at desk/computer.
• Regular need to go up/down stairs.
• Ability to stand for extended periods of time and: stoop, bend, kneel, crouch, balance, climb as part of audit routine.

Regulatory Requirements

• Adhere to all safety policies and procedures, follow cGMP's, and work in a manner consistent with all corporate and regulatory, food safety, quality and sanitation requirements.
• Will comply with all applicable federal, state, and local standards for the manufacture of infant formula and other non-infant nutritional foods.

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.

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.