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QA Analyst/ Jr Engineer

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Company :
doTERRA International LLC

Location :
Pleasant Grove, Utah

Expiry Date :
Mon, 08 Mar 2021 23:59:59 GMT

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Description :
Job Description: Investigates products suspected of not meeting specification, identifying trends of repeat product investigations, working with various departments including QA, QC, R & D, Purchasing, Manufacturing, ME, raw material suppliers, and manufacturers on investigations. Strengths in this position include a Food Science degree with an emphasis in chemistry or microbiology. Additional strengths include a science background in food, dietary supplements, or drugs as well as food engineering, food manufacturing, GMPs (good manufacturing practices), 21 CFR 117, FDA food and dietary supplement regulations. Job Responsibilities: – Works closely with complaint coordinator to obtain complaint reports and files – Coordinates with QA, QC, Legal, R & D, and Product Support for SAER and AER investigations – Reviews customers and international complaint investigations and provide timely root cause and corrective actions as applicable in order to increase consumer satisfaction. – Reviews batch records, retains, testing data, manufacturing, maintenance, and sanitation records as part of complaint investigations – Ensures that product complaints and AERs are investigated in a timely fashion – Provides a summary of issues to Quality Engineer and Quality Director for decisions on investigations – Ensures all documents associated with an investigation are included in the investigation file – Reviews complaints and product return trends to generate weekly and monthly reports on complaint investigation outcomes – Identifies if other batches are implicated as a result of investigations and inform QA management – Identifies if CAPAs are needed to prevent complaint recurrence and improve product quality – Works with Quality Assurance Director to issue and monitor the effectiveness of CAPAs related to complaints and returns – Complies with FDA, cGMP, and other requirements and enforcing adherence to requirements. Job Qualifications: – 2-5 years in dietary supplement Quality Assurance experience required. – BS degree in food science, microbiology, chemistry, biology, or related field required. – Knowledge of business analysis and computer tools: Microsoft Word, Excel, PowerPoint, etc. – Must be able to demonstrate a working understanding of 21 CFR 1 1 1; 1 17; 120 and FSMA. – Must have excellent analytical skills. – Communicate effectively with all levels of personnel, both internal and external (i.e., suppliers, tech. support, etc.) by possessing excellent interpersonal, verbal, and written skills in English, Bilingual English/Spanish preferred. – Discretion and judgment are required. – Outstanding organizational skills, excellent attention to detail, and the ability to multi-task required. – Must have the ability to work as a team, as well as to work independently. – Ability to work with others to facilitate completing work assignments. – Must be able to work in a manufacturing environment and travel to contract manufacturing and warehouse locations as needed to complete investigations and inspections. – Must be able to lift up to 50 lbs. Must be able to walk, stand or sit for 8 hours unaided. Must be able to demonstrate the ability to detect mm level defects visually, take and give oral instructions in a manufacturing environment. – Long periods of standing, bending, and repeated lifting (2-5 lbs) – Must be able to handle moderate noise level (