Quality Document Control Specialist New Allerton, Iowa, United States
ByHeart, Iowa, LA, United States
ByHeart was built on the belief that infant formula should be held to a higher standard. We founded the company on the latest nutrition science, with an unwavering commitment to creating the closest formula to breast milk to drive meaningful health outcomes for babies at the most critical stage of their development.
We spent 10 years doing what no one else had done: conducting the largest clinical trial by a new infant formula brand in 25 years, building our own domestic manufacturing facilities, and developing an innovative formula with a patented protein blend that gets closer to breast milk than any formula before it. By adding the two most abundant breast milk proteins — lactoferrin and alpha‑lactalbumin — at levels closer to breast milk, with broken‑down proteins for easier digestion, we created a breakthrough formula with clinically proven health outcomes, published in a peer‑reviewed medical journal. In less than two years, we became a top 10% product across all of U.S. retail, and nationally accessible in >12,000 retail stores, Amazon and DTC. This wasn’t incremental improvement. It was a fundamentally different approach to infant nutrition.
Our commitment has always extended beyond the product itself. Through our OpenHearted program, we’ve donated over 1,000,000 feeds to families living below the poverty line. And following the 2023 national formula shortage, ByHeart became the only company to build two new domestic manufacturing facilities — working alongside both the Biden and Trump administrations to strengthen the U.S. supply chain and ensure every family has reliable access to clean, high‑quality, rigorously tested formula.
In November 2025, everything we built ByHeart to prevent, happened. Our product became contaminated by an unprecedented pathogen that caused infant botulism. Together with FDA and the world’s leading experts and labs, we’ve led a no‑stone‑unturned audit of every single step of how ByHeart is made. Through that work, ByHeart and FDA have found matching genetic sequences that trace the pathogen back to a third‑party ingredient supplier, and we’ve published peer‑reviewed research that provides critical insight to the industry and scientific community on the testing standards necessary to help ensure this never happens again.
Our mission is more urgent than ever, and we have committed to a set of bold, industry‑leading safety and transparency actions that reflect how seriously we take our responsibility. In the months following the recall, there hasn't been a single day where getting this right wasn't our most important priority. We will return to market only when the evidence supports that we are ready. We’re hiring the people who will help us get there, and build a safer future for all families.
The Quality Document Control Specialist coordinates activities to ensure compliance with company's policies and procedures to meet GMP and regulatory guidelines. High focus on reviewing, editing, and releasing GMP documentation. Support documentation release for all ByHeart facility departments. This role ensures that all procedures, records, specifications, and forms remain current, properly approved, accessible by applicable parties, and compliant with regulatory requirements. The position plays a critical role in maintaining compliance with requirements established by the U.S. Food and Drug Administration for infant formula manufacturing under 21 CFR Part 106 and 21 CFR Part 117.
Reports To:
Quality Regulatory Compliance Manager
Location:
Allerton IA
ROLES & RESPONSIBILITIES
Manages the Document Control System, manually or through programs such as Dot Compliance (a Salesforce-based electronic Quality Management System). Maintains secure storage and retrieval systems for both electronic and hardcopy records.
Works closely with department personnel to ensure the release of key process documentation including but not limited to batch records, quality policies, change control documentation and departmental procedures and associated records.
Maintain high‑quality technical documentation by reviewing, editing, releasing and archiving procedures, work instructions and forms following company's document change procedure.
Responsible for formatting, proper spelling, organization, and clarity of text for any written documents submitted to Document Control.
Manages physical inventory of documents control including documentation in the electronic database of documentation and outside storage.
Assists with documentation preparation and needs during audits, investigations, or regulatory inspections.
Documents and tracks documentation numbering system, managing revision control and ensures only current versions of documents are accessible for operational use. Prompts document review as required.
Maintains document traceability including revision history, approval records, and distribution logs.
Assists with data collection, trending and distribution.
Trains and assists team members in the use of the document control system.
Assists with the coordination of training on newly released procedures, work instructions and forms.
Assists with other Quality Assurance and Regulatory Compliance functions as needed.
Skills & Qualifications
Detail‑oriented, accurate, and highly organized.
Strong technical writing skills with the ability to produce clear and concise documentation
Must have strong trouble shooting and problem‑solving skills
Good communication skills (oral and written) and cross‑functional coordination abilities
Ability to act independently, accept supervision and work quickly and accurately in a fast‑paced environment
Fast, efficient, high‑level user of Microsoft Office applications such as Word, Excel, PowerPoint
Knowledge of electronic document management systems or Salesforce CRM
Ability to maintain confidentiality and data integrity
College degree or BS in Food Science, Quality Assurance, Regulatory Affairs, or related field preferred
2-5 years of document control, quality systems or regulatory compliance experience
Hands‑on QA experience in a GMP manufacturing environment preferred
Sit for long periods to work on a computer.
Wear personal protective equipment, including safety glasses, hair net, beard net (if applicable), gloves, specialized clothing including laboratory scrubs (pants and shirt) and lab coat, and appropriate shoes.
This role is primarily office‑based but may require periodic presence in manufacturing, laboratory, or warehouse areas to support documentation verification and record review.
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.
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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We spent 10 years doing what no one else had done: conducting the largest clinical trial by a new infant formula brand in 25 years, building our own domestic manufacturing facilities, and developing an innovative formula with a patented protein blend that gets closer to breast milk than any formula before it. By adding the two most abundant breast milk proteins — lactoferrin and alpha‑lactalbumin — at levels closer to breast milk, with broken‑down proteins for easier digestion, we created a breakthrough formula with clinically proven health outcomes, published in a peer‑reviewed medical journal. In less than two years, we became a top 10% product across all of U.S. retail, and nationally accessible in >12,000 retail stores, Amazon and DTC. This wasn’t incremental improvement. It was a fundamentally different approach to infant nutrition.
Our commitment has always extended beyond the product itself. Through our OpenHearted program, we’ve donated over 1,000,000 feeds to families living below the poverty line. And following the 2023 national formula shortage, ByHeart became the only company to build two new domestic manufacturing facilities — working alongside both the Biden and Trump administrations to strengthen the U.S. supply chain and ensure every family has reliable access to clean, high‑quality, rigorously tested formula.
In November 2025, everything we built ByHeart to prevent, happened. Our product became contaminated by an unprecedented pathogen that caused infant botulism. Together with FDA and the world’s leading experts and labs, we’ve led a no‑stone‑unturned audit of every single step of how ByHeart is made. Through that work, ByHeart and FDA have found matching genetic sequences that trace the pathogen back to a third‑party ingredient supplier, and we’ve published peer‑reviewed research that provides critical insight to the industry and scientific community on the testing standards necessary to help ensure this never happens again.
Our mission is more urgent than ever, and we have committed to a set of bold, industry‑leading safety and transparency actions that reflect how seriously we take our responsibility. In the months following the recall, there hasn't been a single day where getting this right wasn't our most important priority. We will return to market only when the evidence supports that we are ready. We’re hiring the people who will help us get there, and build a safer future for all families.
The Quality Document Control Specialist coordinates activities to ensure compliance with company's policies and procedures to meet GMP and regulatory guidelines. High focus on reviewing, editing, and releasing GMP documentation. Support documentation release for all ByHeart facility departments. This role ensures that all procedures, records, specifications, and forms remain current, properly approved, accessible by applicable parties, and compliant with regulatory requirements. The position plays a critical role in maintaining compliance with requirements established by the U.S. Food and Drug Administration for infant formula manufacturing under 21 CFR Part 106 and 21 CFR Part 117.
Reports To:
Quality Regulatory Compliance Manager
Location:
Allerton IA
ROLES & RESPONSIBILITIES
Manages the Document Control System, manually or through programs such as Dot Compliance (a Salesforce-based electronic Quality Management System). Maintains secure storage and retrieval systems for both electronic and hardcopy records.
Works closely with department personnel to ensure the release of key process documentation including but not limited to batch records, quality policies, change control documentation and departmental procedures and associated records.
Maintain high‑quality technical documentation by reviewing, editing, releasing and archiving procedures, work instructions and forms following company's document change procedure.
Responsible for formatting, proper spelling, organization, and clarity of text for any written documents submitted to Document Control.
Manages physical inventory of documents control including documentation in the electronic database of documentation and outside storage.
Assists with documentation preparation and needs during audits, investigations, or regulatory inspections.
Documents and tracks documentation numbering system, managing revision control and ensures only current versions of documents are accessible for operational use. Prompts document review as required.
Maintains document traceability including revision history, approval records, and distribution logs.
Assists with data collection, trending and distribution.
Trains and assists team members in the use of the document control system.
Assists with the coordination of training on newly released procedures, work instructions and forms.
Assists with other Quality Assurance and Regulatory Compliance functions as needed.
Skills & Qualifications
Detail‑oriented, accurate, and highly organized.
Strong technical writing skills with the ability to produce clear and concise documentation
Must have strong trouble shooting and problem‑solving skills
Good communication skills (oral and written) and cross‑functional coordination abilities
Ability to act independently, accept supervision and work quickly and accurately in a fast‑paced environment
Fast, efficient, high‑level user of Microsoft Office applications such as Word, Excel, PowerPoint
Knowledge of electronic document management systems or Salesforce CRM
Ability to maintain confidentiality and data integrity
College degree or BS in Food Science, Quality Assurance, Regulatory Affairs, or related field preferred
2-5 years of document control, quality systems or regulatory compliance experience
Hands‑on QA experience in a GMP manufacturing environment preferred
Sit for long periods to work on a computer.
Wear personal protective equipment, including safety glasses, hair net, beard net (if applicable), gloves, specialized clothing including laboratory scrubs (pants and shirt) and lab coat, and appropriate shoes.
This role is primarily office‑based but may require periodic presence in manufacturing, laboratory, or warehouse areas to support documentation verification and record review.
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.
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.
#J-18808-Ljbffr