Quality Document Control Specialist

ByHeart • Allerton, IA

6h • Onsite

About The Position

ByHeart was founded on the belief that infant formula should be held to a higher standard, with an unwavering commitment to creating the closest formula to breast milk. The company spent 10 years conducting the largest clinical trial by a new infant formula brand in 25 years, building its own domestic manufacturing facilities, and developing an innovative formula with a patented protein blend. This breakthrough formula, with clinically proven health outcomes, became a top 10% product across U.S. retail. ByHeart also has a commitment to social responsibility through its OpenHearted program and efforts to strengthen the U.S. supply chain. Following a product contamination incident in November 2025, ByHeart has led a thorough audit, identified the source, and published research to prevent future occurrences. The company is committed to industry-leading safety and transparency actions and is hiring to build a safer future for all families.
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 specialist 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.

Requirements

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

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees