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Quality Assurance Administrator

Celsius

Quality Assurance Administrator

Role Description

The Quality Assurance Administrator helps maintain the regulatory compliance and quality assurance functions for Celsius Inc. This position’s overall responsibility to execute comprehensive regulatory strategies and ensure Celsius products comply with domestic and international regulations and quality expectations.

 

Job Skills / Requirements

Must be able will work in an FDA cGMP regulated environment and keep up with latest regulations and quality assurance standards; specifically, FDA 21 CFR 110 & 111 guidelines for dietary supplement compliance.

 

The job responsibilities included but not limit to:

 

   Quality Assurance:

  • Maintain the development/revision of QC documents (MMR, IP, FP, PMS, RMS, PS, etc.)

  • Ensure compliance with appropriate SOP’s according to US FDA and cGMP regulations

  • Manage product set up documents bundle (artwork, MI, QC documents, product specifications/certifications, etc.) to the co-packer

  • Review production BOM documents from co-packer prior 1st production, advise manufacturing facilities to correct any discrepancies

  • Review and approve production test COAs, microbiological & batch records

  • Monitor trends of production specifications (Brix, TA, etc.) and work with suppliers to provide solutions for   out of spec results

  • Coordinate with co-packer to solve any quality related issues, create CAPA and follow up with status

  • Source the 3rd party lab to run specific product tests, review and approve test invoices and correct any mistakes

  • Contribute quality expertise to production, oversee the implementation of the following programs: MSDS, allergen control, HACCP, Traceability & Recall, etc.

  • Back up global operations coordinator to work with co-packers on product testing, submit quarantine form to   release inventories for shipment

  • Provide responses to customer service to help ease consumer concerns regarding products

     

   Regulatory Affairs:

  • Monitor federal laws/regulations, analyze the information, ensures that technical solutions are in compliance with regulatory guidelines and updates

  • Review vendor cGMP qualification form and make approve/disapprove decision

  • Monitor formula/ ingredient list changes and update regulatory documents database accordingly

  • Conduct regulatory compliance research to provide answers to management regarding product related questions

  • Fill up and submit regulatory documents from customers, vendors and government agencies

  • Work with consultant to ensure regulatory compliance of Celsius products and documentations

  • Conduct yearly stability test on products to ensure claim compliance

  • Oversee the FDA registration to make sure required information are updated on time

 

 

   Other Requirements Include:

  • Proficiency in all MS Office applications (Excel, PowerPoint, Outlook & Word)

  • Excellent technical research skills

  • Minimum of 3-5 years of regulatory and quality experiences

  • Production and product development experiences are a plus

    Key Competencies

  • Excellent communication skills: this position interacts with all departments and all levels of management Internally. This position will also interacts with the US FDA, industry organizations, consultants, vendors.

  • Strong analytical skills, good with Excel

  • Must be organized and able to work independently

     



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