R&D Document Control Specialist

We are seeking an experienced R&D Document Control Specialist to join our Product Development team. The R&D Document Control Specialist will be responsible for managing and maintaining all documentation related to research and development activities. This includes ensuring compliance with regulatory requirements, maintaining accurate records, and facilitating efficient document workflows. The ideal candidate will have a keen eye for detail, strong organizational skills, and a thorough understanding of documentation processes within the supplement or pharmaceutical industry. This position reports to our Vice President of Product Development.

Primary Duties and Responsibilities:

• Document Management:
  • Develop, implement, and maintain document control processes and systems to manage R&D documentation.
  • Organize, catalog, and maintain all R&D documents, including research data, formulations, protocols, reports, and regulatory submissions.
  • Ensure all documents are accurate, up-to-date, and accessible to authorized personnel.
• Regulatory Compliance:
  • Ensure all R&D documentation complies with regulatory requirements (FDA, GMP, etc.) and industry standards.
  • Assist in the preparation and submission of regulatory documents to appropriate agencies.
  • Keep abreast of changes in regulatory requirements and update documentation practices accordingly.
• Workflow Management:
  • Manage the document review and approval process, ensuring timely review and feedback from relevant stakeholders.
  • Track document revisions and maintain a comprehensive history of changes.
  • Coordinate with cross-functional teams to ensure accurate and consistent documentation practices.
• Quality Assurance:
  • Conduct regular audits of R&D documents to ensure accuracy, completeness, and compliance.
  • Implement corrective actions for any identified documentation deficiencies.
  • Support the development and maintenance of Standard Operating Procedures (SOPs) related to document control.
• Training and Support:
  • Provide training and support to R&D team members on document control processes and systems.
  • Serve as a point of contact for any document control-related inquiries or issues.

Qualifications:

• Bachelor’s degree in a relevant field (e.g., Life Sciences, Chemistry, Quality Management).
• Minimum of 3 years of experience in document control within the supplement, pharmaceutical, or related industry.
• Strong knowledge of regulatory requirements and industry standards (FDA, GMP, etc.).
• Proficient in document management systems and software.
• Excellent organizational skills and attention to detail.
• Strong communication and interpersonal skills.
• Ability to manage multiple tasks and prioritize effectively.
• Familiarity with R&D processes and workflows.

Preferred Qualifications:

• Experience with electronic document management systems (EDMS).
• Certification in document control or regulatory affairs.
• Experience in a GMP-regulated environment.

Salary: $65,000-75,000 DOE

Location: Riverton, Utah (hybrid)

Position Type: Full-time

Benefits: 

• Paid time off (flexible)
• Paid holidays
• Insurance: Health, dental & vision
• 401(k) + Company match
• Free product allowance