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, 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.