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DM
Stability Coordinator
doTERRA Manufacturing · Pleasant Grove, UT, United States
About The Role
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 RESPONSIBILITIES
- Develop stability studies including study execution and data management in alignment with regulatory guidance documents, stability protocols, and standard operating procedures.
- Clean and maintain all stability equipment.
- Ensure preventative maintenance and calibrations are performed regularly on all stability equipment.
- Perform stability pulls and coordinate sample preparation and submissions.
- Perform data review and trend evaluation of stability results.
- Write and review documents needed for stability, such as standard operating procedures (SOPs), change control requests, protocols, trend reports, etc.
- Keep stability data and files well-organized.
- Work closely with R&D, QA, and Regulatory departments to ensure stability testing is performed on required products in a timely manner.
- Report any compliance challenges or other stability issues to the Stability Supervisor.
- Ensure that stability samples are analyzed, and the data is reported in a timely manner.
- Ensure stability data is shared with appropriate departments in a timely manner.
- Comply with ICH, FDA, TGA ,cGxP, and other guidelines.
- Prioritize and plan tasks to achieve daily workload.
- Remain current on all required trainings.
- Comply with all laboratory safety procedures.
- Participate in internal and regulatory inspections and audits when needed.
- Participate in all continuous improvement activities.
- Must be available for ad hoc meetings, calls, or questions during business hours.
- Maintain positive relationships in the workplace by treating others with respect, dignity, and integrity.
- May be asked to perform non-routine work on occasion to assist the department.
- Other related duties as assigned.
JOB QUALIFICATIONS
- Education and Experience:
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- 1-2+ years of experience with QC stability and sample management preferred.
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- Some college education preferred.
- Required Knowledge, Skills, and Abilities:
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- Knowledge of ICH, cGxP, FDA, TGA, and other applicable regulations.
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- Ability to communicate in a timely manner by reading, writing, and speaking in English, including in person real-time communication.
- Ability to work under pressure and prioritize and plan tasks to achieve daily workload.
- Ability to traverse varying distances and travel between floors of the building. Traveling between buildings (outside) may be required occasionally.
- Must be able to elevate and/or move up to 40 pounds, with assistance.
- Must be able to work in close proximity to products with strong aromas.
- Must maintain positive relationships in the workplace by treating others with respect, dignity, and integrity.
- Basic knowledge of Good Laboratory Practices.
- Advanced organizational skills.
- Mathematical and deductive reasoning skills.
- Project management and problem solving skills.
- Knowledge of recordkeeping requirements.
- Proficient in Microsoft Office, basic computer programs, and laboratory software.
doTERRA International, LLC. is committed to employing a diverse workforce. Qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, gender expression, protected veteran status, or disability.
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