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Quality Document Control Specialist

ByHeart
CompanyByHeart
CategoryOperations & Admin
LocationAllerton
RemoteOn-site (inferred)
EmploymentNot stated
LevelNot stated
SalaryNot stated by the employer
Posted22 Apr 2026
Last verified30 Jul 2026
SourceEmployer career page (greenhouse)
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Description
About ByHeart ByHeart was built on the belief that infant formula should be held to a higher standard. We spent seven years developing an evidence-based formula from the ground up, running the largest clinical trial by a new infant formula brand in 25 years, and building our own manufacturing facilities. ByHeart is a nutrition company, specializing in infant formula, committed to the highest manufacturing and safety standards in the industry — now expanding that same standard across a broader range of nutrition products. We own three domestic U.S. facilities and have invested heavily in infrastructure, R&D, and in-house quality systems, able to provide third-party incubation and manufacturing support for leading ingredient and end-product nutrition brands. We are now actively expanding operations at our Allerton, Iowa facility. Our factory is running and we are focused on scaling our manufacturing to support a broader range of dairy nutrition products. This is a new and growing chapter for the facility and we're hiring the people who will help us build it. ROLE DESCRIPTION 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, ac
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