Quality & Regulatory Document Specialist

GU EnergyBerkeley, CA
3d$78,000 - $86,000Onsite

About The Position

GU Energy Labs is a family-owned market-leading global sports nutrition brand, and we are looking for a Quality & Regulatory Document Specialist to join our team! The Quality and Regulatory team is responsible for ensuring the quality and safety standards of GU products, and compliance with food/supplements regulations. Quality & Regulatory Document Specialist manages compliance and quality control documents for GU’s full line of sports nutrition products to ensure we meet or exceed FSMA and Dietary Supplement (21 CFR 111) guidelines. The ideal candidate connects with GU’s core values of Athleticism, Accountability, Innovation, Collaboration, Longevity, and Love. They are enthusiastic about building and growing quality and compliance programs that actively contribute to continuous improvement.

Requirements

  • BS/BA degree required; Food Science or similar major preferred
  • 2+ years of Quality and Food Safety experience in the food or supplement industry
  • Experience working with Quality Management Tools (Redzone, Safefood 360, Excel Spreadsheets, etc.)
  • Strong written and verbal communication skills
  • Organized and sound judgment and problem-solving ability
  • Analytical and adaptable in changing environments
  • Effective under pressure with strong decision-making skills
  • Excellent customer service skills
  • Ability and willingness to work hands-on as needed
  • Occasional time with employees in the plant during morning or evening shifts required

Nice To Haves

  • PCQI certification is a plus
  • Knowledge of or experience with the following is not required but preferred...
  • Foreign regulations
  • HACCP, FSMA, 21 CFR Part 110/111/101/117, Kosher, and other regulatory issues
  • GFSI, GMP, GFCO, Vegan, Kosher, Halal, and Organic certification implementation experience
  • Experience with internal/third party audits (NSF, AIB, etc.)

Responsibilities

  • Partners with the Quality Team to ensure compliance of all product documentation within an evolving regulatory environment.
  • Is the go-to resource for regulatory and quality documents and document controls.
  • Creates, maintains, and organizes documentation (record keeping) for all the ingredients, finished products (BPRs), and testing results (COAs).
  • Ensures all documentation is maintained, in compliance, and organized for easy access.
  • Collaborates with the Quality Team in approval processes, including but not limited to: Raw materials Finished products Vendors (including raw material suppliers, packaging suppliers, third-party laboratories)
  • Responsible for maintaining the Vendor Qualification Program, conducting vendor evaluations, and establishing re-evaluation frequencies in accordance with program requirements
  • Accurately compiles Quality Control data and prepares Certificates of Analysis (COAs) and other QC reports for management review
  • Supports the maintenance and review of co-packer documentation, including qualification records, to help ensure all files remain accurate, complete, and up to date
  • Helps maintain audit-ready documentation for internal and external inspections
  • Assist the regulatory function with document requests from international distributors and customers
  • Provide support for GU-HQ production quality functions as needed
  • Other duties as required or assigned to support business needs
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