Quality Assurance Administrator
Quality Assurance Administrator
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:
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
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
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