Quality Assurance Specialist I

doTERRA International LLC•Pleasant Grove, UT

3d•Onsite

About The Position

At doTERRA we encourage all employees to seek out opportunities that will expand their skill set. We strive to help achieve personal career goals by providing opportunities of growth and movement throughout the company. Job Description: Investigates products suspected of not meeting specifications, identifies recurring issues or trends, and collaborates with cross-functional teams (e.g., QA, QC, R&D, Purchasing, Manufacturing, and suppliers) to support investigations.

Requirements

BS degree in food science, microbiology, chemistry, biology, nursing, engineering, or related field preferred, but not required.
1-3 years in Quality Assurance experience required.
Must be able to demonstrate working understanding of 21 CFR 111 subpart O; 21 CFR 117, 21 CFR 120, 21 CFR 211, 21 CFR 700.3, ISO 22716, and FSMA.
Must have analytical and problem solving 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 ability to detect mm level defects visually, take and give oral instructions in a manufacturing environment.
Long periods of standing, bending, and repeated lifting (2-50 lbs.)
Must be able to handle moderate noise level (<75db)
Must be able to work in manufacturing environments (clean rooms and warehouse)

Nice To Haves

1-3 years of Production Experience preferred but not required.
Related Quality Assurance Certificate, or Six Sigma Certificate preferred.
Knowledge of business analysis and computer tools: Tableau, Microsoft Word, Excel, PowerPoint, etc.

Responsibilities

Works closely with Global Complaint Leader to manage complaint reports and files.
Assess risk and monitor all complaint report types for accuracy and to determine if need for investigation is warranted.
Coordinates with relevant internal teams and suppliers (e.g., QA, QC, Legal, R&D, Product Support, and others as needed) to support investigations.
Provides timely root cause and follow-up as applicable in order to increase consumer satisfaction and safety.
Reviews all relevant documentation related to investigation risk level, including but not limited to Certificate of Analysis (COA), specifications, batch records, retain samples, testing data, and manufacturing, maintenance, and sanitation records.
Reviews complaint trend data and generates reports to support investigations or as needed/requested.
Ensures all complaint types (product complaints and AERs) are investigated and closed within 90 days of initiation. Any delays or challenges in meeting closure timelines—particularly for TGA investigations—must be communicated promptly to the Global Complaint Leader.
Communicates trending complaint reports to the Global Complaint Leader.
Ensures all documents that are not easily retrieved, and are associated with an investigation are included in the investigation file.
Provides investigation summary of issues to Global Complaint Leader or designee for investigation review.
Identify if other batches are implicated during investigation, and report findings to Global Complaint Leader.
Thoroughly review documentation received from internal and external sources related to investigation, such as investigation reports received from suppliers.
Complies with all regulatory bodies, cGMP and other requirements and enforcing adherence to requirements.