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Position Summary:
The stability coordinator maintains Stability chamber and company’s stability program.

Tasks/ Responsibilities including but not limited to:
• Composes stability protocols. Pulls stability samples at the appropriate dates.
• Maintains accurate records of stability samples. Coordinates stability testing activities and stability results. Writes stability summaries and stability reports.
• Assists with stability sample testing as needed. Makes conclusions about the data and trends when necessary.
• Communicates with product development regarding the status of new formula and new products on stability.
• Communicate effectively with other departments within the organization and function within a team environment.
• Assist supervisor/Manager with investigations such as customer complaints, non-conformance and Out of Specifications.
• Perform other assigned duties as may be required in meeting company objectives.

Skills and Abilities:
• Technical Capacity
• Communication Proficiency
• Problem Solving/Analysis
• Decision Making
• Initiative
• Results Driven
• Organization Skills


Education and Experience

• Knowledge of current GMP regulations for laboratory and ICH guidelines for the stability area.
• Must have good writing skills and be detail oriented. Understanding scientific data and the interpretation of data is a must in order to discern trends and make calls about product stability/shelf life and to determine and to determine viability of new product formulations on test. Must be a self-starter and be motivated to ask questions regarding formulations and be a true owner of the process and the data that is collected. Must be able to troubleshoot and work out problems in testing such as comparison of methods, out of specification (OOS) results and out of trend (OOT) data. Hands on laboratory experience are a must as well even though this position will not be a bench chemist.


Working Conditions/Job Environment
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Occasionally the work environment may be loud.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions.