Regulatory & Document Coordinator

If you have a passion for maintaining quality standards and enjoy working in a dynamic environment, this role is perfect for you!

A large manufacturing company on the Kona coast is looking for a detail-oriented and organized individual to ensure regulatory compliance and document control within their organization.

Apply today for immediate consideration!

Hours

Full-time, Monday to Friday 7:30am-4:00pm

Location

Kailua-Kona, Big Island

Pay

$23 to $26 an hour

Responsibilities

• Coordinate efforts in maintaining registrations and certifications.
• Review product labels and marketing materials for compliance. 
• Support new product development and international export efforts.
• Manage document control systems and ensure records are appropriately retained.
• Support product release through batch record review and COA generation.
• Organize and audit GMP records and maintain master files.
• Provide sales support for customer inquiries and documentation requests.
• Assist with external audit preparation and serve as a backup audit scribe.
• Manage documentation for contract manufacturers, co-packers, and vendors.
• Audit Quality Management System through periodic reviews of SOPs.
• Perform other duties as assigned.

Qualifications

• Bachelor's degree or equivalent combination of work experience and education preferred.
• Previous work experience with GMP standards preferred.
• Certified Quality Improvement Associate through ASQ or equivalent preferred.
• Proficiency with Microsoft Office (Word, Excel, Outlook).
• Strong communication (verbal, written, interpersonal) skills.
• Strong analytical, organizational, multitasking, and problem-solving skills.
• Ability to work independently and as a part of a team.
• Ability to lift up to 40lbs.
• Ability to pass pre-employment state and federal background check and drug test.