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Quality & Regulatory Document Specialist

GU Energy
Posted 21 days ago, valid for 18 days
Location

Berkeley, CA 94701, US

Salary

$65,000 - $78,000 per year

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Contract type

Full Time

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Sonic Summary

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  • GU Energy Labs is seeking a Quality & Regulatory Document Specialist to join their Quality and Regulatory team in Berkeley, California.
  • The role requires a BS/BA degree and a minimum of 2 years of Quality and Food Safety experience in the food or supplement industry.
  • The specialist will manage compliance and quality control documents to ensure adherence to FSMA and Dietary Supplement guidelines.
  • The position offers a salary range of $78,000 to $86,000 and emphasizes the importance of collaboration and continuous improvement.
  • Candidates should possess strong communication skills and be organized, with experience in quality management tools and regulatory compliance preferred.

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. 

 

PRIMARY 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:
    1. Raw materials
    2. Finished products
    3. 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



QUALIFICATIONS

  • 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.)
  • 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.)
  • 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


This role is not eligible for visa sponsorship.


Location

Berkeley, California

Department

Quality & Regulatory

Employment Type

FT Employee

Minimum Experience

Mid-level

Compensation

$78,000 - $86,000




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