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Regulatory & Document Coordinator

4 months ago

KailuaKona, United States ALTRES Staffing Full time
Regulatory & Document Coordinator (105153)

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.