E-3 Visa Quality Control Specialist Jobs

ABOUT BYHEART

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.

ROLE DESCRIPTION

The Quality Document Control Specialist coordinates activities to ensure compliance with company policies and procedures to meet GMP and regulatory guidelines. This role focuses heavily on reviewing, editing, and releasing GMP documentation, and supports documentation release needs across all ByHeart facility departments. The role manages the Document Control System, oversees documentation formatting and clarity, maintains controlled records, supports audit documentation needs, and provides training on the document control system and newly released documents.

Reports To: QA Regulatory Compliance Manager

Location: Allerton IA

ROLES & RESPONSIBILITIES

• Coordinate activities to ensure compliance with company policies and procedures to meet GMP and regulatory guidelines.
• Review, edit, and release GMP documentation, supporting documentation requirements for all ByHeart facility departments.
• Manage the Document Control System, Intelex.
• Work closely with department personnel to ensure release of key process documentation, including batch records, quality policies, and departmental procedures.
• Review, edit, and release procedures, work instructions, and forms in accordance with the company’s document change procedure.
• Ensure proper formatting, spelling, and clarity for all documents submitted to Document Control.
• Manage physical inventory of controlled documents, including documentation stored within the electronic database and off-site storage.
• Assist with documentation needs during audits.
• Document and track the documentation numbering system.
• Train and assist team members in use of the document control system.
• Assist with training on newly released procedures, work instructions, and forms.
• Assist with other Quality Assurance and Regulatory Compliance functions as needed.

SKILLS & QUALIFICATIONS

• Attention to detail.
• Strong troubleshooting and problem-solving skills.
• Good communication skills (oral and written).
• Ability to act independently, accept supervision, and work quickly and accurately in a fast-paced environment.
• Fast, efficient, high-level user of MS Word and Excel.

EDUCATION & EXPERIENCE REQUIREMENTS:

• College degree or BS, preferably in biological science.
• 5 years of hands-on QA experience in a GMP manufacturing environment.

Physical Requirements:

• Ability to 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 (lab scrubs and lab coat), and appropriate shoes.
• Ability to work in constrictive gowning, including facial masks, for extended periods.

REGULATORY REQUIREMENTS:

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

We’re excited about your interest in joining ByHeart! Our Talent Acquisition team reviews applications in the order they are received and will reach out directly to schedule interviews. We kindly ask that you refrain from contacting hiring managers or current employees directly.

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.