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Quality Assurance Specialist
Genesis Pure 9 reviews - Frisco, TX




Job Descriptions:
Do you want to be aligned with a brand that is synonymous with nutrition, wellness and positive change?
Can you jabber about CFR TITLE 21 PART 111?
Are you up-to-date about cGMP for Dietary Supplements?
Can you comprehend and enforce SOPs?
…if you answered YES to these questions, then we invite you to learn more about a Career Opportunity with Genesis PURE™.
Here at Genesis PURE, we have set an ambitious course for ourselves as a company. Genesis PURE envisions a world free of obesity, preventable chronic disease and prescription drug dependence. We help people get back on the road to Whole Health by helping them address the root causes of their health problems, instead of suppressing the symptoms of an unhealthy lifestyle. Our proprietary products encompass: Live PURE Nutrition, Live PURE Performance, and Live PURE Beauty.
Our corporate home office is nearby Main Street and the FC Dallas Soccer Stadium in downtown Frisco, TX. We offer a casual workplace style and a culture based on teamwork, collaboration, creativity and respect.....Oh, and we tend to get passionate about the Genesis PURE products and "Whole Health"!
Presently, we seek to appoint a QA Specialist , a key appointment that focuses on supporting operational deliverables to assure the safety, quality and security of products produced by or for Genesis PURE™. Duties may include, reviewing regulatory requirements (FDA Title 21 CFR, Part 111 /cGMP) for safety and labeling; assessing customer complaints and product returns; and compiling and preparing materials for submission. Responsibilities:
Ensure that all Genesis PURE™ dietary supplements and ingredients meet specifications for identity, purity, strength and composition;
Ensure Genesis PURE™ products are manufactured, packaged, labeled and held under conditions to prevent adulteration;
Monitor production for compliance with all federal, state, and local regulatory requirements, as well as internal corporate programs and management requirements;
Observe, follow and/or execute the Corrective and Preventative Actions (CAPA) procedures, including the identification and input of quality data, routine analysis of quality data, and the recording and maintenance of the related raw data;
Have the authority to approve or reject procedures, specifications, controls, test methods, and results that may impact the purity, quality and composition of ingredients or finished products;
Analyze and comprehend changes or revisions to all relevant documentation such as SOPs, methods, record keeping, formulas etc.; implement corrective actions when documentation procedures are not being followed;
Conduct periodic Good Manufacturing Practice (GMP) internal audits of production sites;
Establish, qualify and maintain interactions with contract laboratories; develop constructive and cooperative relationships with their key personnel; review and approve the documentation setting forth the basis for qualification of all suppliers;
Perform appropriate tests of components, ingredients, finished products, packaging and labels to ensure conformance to specifications;
Review and approve decisions for investigating product complaints as well as the findings and follow-up action of any investigation performed per CAPA.

Required Experience:
Bachelor of Science (BS) degree in a related field;
1 - 3 years of relevant work experience in Quality Assurance, Quality Control, Safety, Regulatory Affairs, Compliance, and/or related field;
Demonstrated knowledge and understanding of quality disciplines and concepts related to the manufacturing, packaging, labeling and/or holding operations for Dietary Supplements, Food and/or Beverages.
General knowledge of regulatory history, guidelines, standards and precedents specific to the Dietary Supplements sector;
Capacity to comprehend FDA Title 21 CFR, Part 111 / Current Good Manufacturing Practice;
Ability to comprehend and assist in the definition of CAPA procedures;
Proficient communications skills as well as ability to translate technical issues into understandable, actionable language;
Effective judgment to be applied throughout the QA/RA process;
Analytical skills, displaying an ability to gather, integrate, relate and compare data from various sources, ensuring the data is reliable, accurate and complete;
Detail orientation and organizational skills to ensure related tasks are completed timely and accurately;
Proficient use of information systems and databases to collect, organize and retrieve data.
From: Genesis Pure


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