Technical Services Stability Coordinator
USANA Health Services - Salt Lake City, UT

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The Stability Coordinator will assist the technical services manager in stability planning, execution, reporting, and trending, while ensuring compliance with U.S. and international stability regulations. In addition, the stability coordinator will maintain stability data from contract manufacturers and suppliers.

Duties/Responsibilities:
Essential Functions
• Assist in planning new and ongoing stability studies for drug products, dietary supplements, foods, and cosmetics and acquire all documentation required for studies.
• Write stability protocols for planned studies in accordance with applicable regulatory requirements.
• Identify suitable product lots for planned studies, arrange for lots to be sampled, and stage samples.
• Responsible for the pulling of samples at designated time points and transfer to laboratory for testing.
• Review data, update/write stability reports, and trend stability data.
• Assist in the investigation and resolution of deviations and OOS generated in stability studies.
• Monitor and maintain stability chambers.
• Monitor stability sample inventory on a regular basis.
• Revise and update SOPs as needed.
• Assist in the revalidation of stability chambers.
• Adhere to quality system policies, procedures, processes, and comply with cGMP and GLP.
• Assist with the preparation and review of stability documentation for regulatory submission and approval.
• Acquire and maintain stability data for contract manufactured product and raw materials.
• Audit contract manufacturers and suppliers as assigned. Additional Job Functions
• Write protocols and reports and execute assigned equipment qualification and validation studies.
• Assist with product process improvement projects.
• Assist in the investigation of customer complaints.
• Perform other duties as assigned or needed. Essential Physical Requirements
• Frequently involves sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Involves a variety of physical activities including: Keying Repetitive motions
• Visual acuity required is the minimum standard for use with those whose work with details, largely with preparing and analyzing data and figures, accounting, transcription, computer terminals, extensive reading. Typical Physical Requirements
• May involve light work: Exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently and/or a negligible amount of force constantly to move objects.
• Involves a variety of physical activities including: Lifting Feeling Talking Machines Typically Operated
• Computer
• Process and laboratory equipment under qualification. Typical Environmental Conditions
• The worker is not substantially exposed to adverse environmental conditions. This is a typical office or administrative environment
Qualifications:
Qualifications/Knowledge, Skills, & Abilities Requirements
• A bachelor's degree or equivalent experience in a life sciences field required.
• Minimum 2 years experience in pharmaceutical, nutraceutical, cosmetics or medical device regulated industry.
• Requires solid knowledge of U.S. and international stability regulations for drug products, dietary supplements, cosmetics, and foods.
• Strong written and oral communication skills with a proficiency in the English language.
• Detailed and analytic oriented abilities.
• Must be willing to learn new tasks and procedures.
• Ability to supervise projects and give directions.
• Ability to perform all essential position duties and responsibilities, with or without reasonable accommodation and without posing a direct safety threat to others or self, in an efficient and effective manner.
Salary Range*:
US Grade 11

Location:
Salt Lake City

Posting Date:
03/22/2013

Open Until Filled

Contact:
hrusana@usana.com

*Salary Disclaimer - The salary listed is a minimum only or refers to an internal grade. Final salary is commensurate with related skills, education, experience and abilities and will be determined in the interview.

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USANA Health Sciences is one of America’s leading companies in the field of health and nutrition. USANA helps improve the lives of...