Full-Time

Quality Assurance Operations Manager

Posted on 6/21/2024

ByHeart

ByHeart

51-200 employees

Produces and sells infant formula

Food & Agriculture
Healthcare

Junior, Mid

Allerton, IA, USA

Eligible for relocation support for candidates moving to Allerton, IA.

Category
QA & Testing
Quality Assurance
Required Skills
Management
Requirements
  • 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.
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.

ByHeart produces and sells infant formula, focusing on providing a product that closely resembles breast milk. Their formula features a patented protein blend made from organic, grass-fed whole milk, which is healthier than the skim milk commonly used in other formulas. This product has been clinically tested and is designed to offer benefits such as easier digestion, reduced spit-up, softer stools, better nutrient absorption, efficient weight gain, and longer intervals between nighttime feeds. Additionally, it supports brain and eye development, immune health, and gut health. ByHeart stands out from competitors by maintaining high quality standards, as evidenced by their Clean Label Project Purity Award, which involves rigorous testing for contaminants. The company's goal is to ensure that infants receive safe, nutritious, and high-quality formula, contributing to their overall health and development.

Company Stage

Late Stage VC

Total Funding

$248M

Headquarters

New York City, New York

Founded

2016

Growth & Insights
Headcount

6 month growth

1%

1 year growth

0%

2 year growth

10%
Simplify Jobs

Simplify's Take

What believers are saying

  • ByHeart raised $95M to expand its manufacturing and production capabilities.
  • Increasing demand for organic products aligns with ByHeart's grass-fed whole milk formula.
  • The rise of e-commerce offers ByHeart opportunities beyond traditional retail channels.

What critics are saying

  • Competition from goat milk-based formulas like Kabrita could impact ByHeart's market share.
  • Reliance on globally-sourced ingredients poses potential supply chain vulnerabilities.
  • High costs of organic ingredients may affect ByHeart's pricing and profit margins.

What makes ByHeart unique

  • ByHeart uses organic, grass-fed whole milk, unlike competitors using skim milk.
  • The company's patented protein blend closely mimics breast milk's nutritional profile.
  • ByHeart has received the Clean Label Project Purity Award for high-quality standards.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Unlimited Paid Time Off

Parental Leave

401(k) Company Match

Company Equity

INACTIVE