Sr. Quality System Specialist

The Sr. Quality System Specialist will be reporting to the Quality Director. This position will actively participate in authoring, reviewing, and maintaining the quality documents and release of dietary supplements manufactured by third party.

Job Responsibilities:

• Assisting in the achievement of company objectives and KPIs
• Author, co-coordinate, close and track the change controls throughout the life cycle
• Author, review and track the product specifications and standard operating procedures
• Maintain the quality document workflow from effective-release -obsolete-archive
• Review/approve the release documentation including certificate of analysis/compliance, test results, Batch records from respective supplier and or contract manufacturer
• Perform incoming inspections/examination and generate release documents and release the products as per the procedure
• Perform review of truck inspection report in accordance with approved company processes and procedures
• Maintain the sample inventory
• Schedule product testing with contract testing laboratory and collect testing results for product release
• Maintain the tracking of each product/raw material/packaging component lot released
• Keep up to date with compliance and regulation guidelines within the dietary supplement industry
• Maintain GMP training records and notify other departments of the required training when needed
• Review the documents received from suppliers/vendor and maintain them properly
• File current and obsolete quality documents accurately and neatly, such as release documents, change controls, specifications, training records, artworks, formula cards, product master list etc.
• Support agency, internal and/or external audits
• Drive Continuous Process Improvement focused on Quality related processes

Job Qualifications/Skills:

• Bachelor's degree or related experience in a technical field - Degree not required in case of relevant experience
• Knowledge and experience working under GDP/cGMP, FDA or some other regulated field preferred
• Knowledge of Dietary Supplement requirements specified under CFR 111, preferred.
• A minimum of 5 years of experience in a QAQC function or position performing incoming inspection/testing and product release
• Ability to manage day-to-day workload with minimal supervision
• Basic knowledge of continuous improvement principles and practices
• Good written and oral communication skills in English
• Computer skills including MS Office products required
• Ideally experienced using Quality documentation software