Quality Document Control Specialist

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.