Strategic Change Control & Documentation Specialist

HKA Enterprises; Rocky Mount (NC); On-site; USD 75,000 - 105,000; Full time

Job summary

HKA Enterprises is seeking a documentation specialist to support cGMP compliance and quality systems. The role focuses on implementing documentation systems, coordinating change control, and reviewing procedures to ensure alignment with regulatory guidelines.

Ideal candidates will have strong technical writing abilities, project management skills, and experience with electronic document management systems in a pharmaceutical setting.

Qualifications

• Must meet education/experience combinations listed in the posting.
• Strong knowledge of cGMP, Data Integrity and ALCOA principles.
• Proficiency in document formatting and word processing.

Responsibilities

• Prepare and review essential documentation, including Good Manufacturing Practices.
• Create and manage change controls, change notifications, and change authorizations.
• Implement documentation systems and review procedures and forms.
• Provide input on quality control procedures and documentation for projects.
• Provide technical writing, editing, and design support for policies and training materials.
• Collaborate to develop change management plans and assess impact.

Skills

cGMP

Data Integrity

ALCOA principles

Word processing

Document formatting

Education

High school diploma

Associate’s degree

Bachelor’s degree

Master’s degree

Tools

Microsoft Word

Excel

PowerPoint

Visio

Job description

HKA Enterprises is seeking a documentation specialist to support cGMP compliance and quality systems. The role focuses on implementing documentation systems, coordinating change control, and reviewing procedures to ensure alignment with regulatory guidelines.

Ideal candidates will have strong technical writing abilities, project management skills, and experience with electronic document management systems in a pharmaceutical setting.