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Stability Coordinator

Department: Stability
Location: West Columbia, SC

STABILITY COORDINATOR

Position Summary:

  • Assure stability data is reviewed; products selected for testing, write stability protocols, prepare stability reports, upkeep of stability chambers and verify chamber charts, and manages personnel issues. 
  • Complete Product Annual Reviews for all marketed products.
  • Assists with additional work duties or responsibilities as evident or required.
  • Performs other duties as assigned or apparent.

Primary Accountabilities:

NOTE: The primary accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

  • Complete Product Annual Reviews for all marketed products which include tracking and trending stability data and results.
  • Ensures that all aspects of stability operations comply with cGMP
  • Analyze and manage the distribution of samples for testing at designated time points.
  • Prepare the Stability Protocols and the Reports.
  • Initiates the selection of products for stability studies and the review of stability data.
  • Responsible for the upkeep of the stability chambers including verification and monitoring of the charts/alarm systems for all chambers.

Knowledge, Skills & Abilities:

  • Bachelor’s degree or equivalent in science or 2-3 years related experience in the pharmaceutical industry.
  • This position requires a technical background with understanding of USP/NF, cGMP, FDA, and laboratory safety regulations. 
  • Should have good understanding of quality assurance/quality control, stability programs and tracking and trending of stability data.
  • Experience with data and trending analysis (MS Excel), and proficiency with MS Word is required. 
  • Must have good organizational skills and be able to manage multiple projects or assignments at one time. 
  • Specific expertise, skills and knowledge within stability coordination gained through education and experience.
  • The ability and willingness to change direction and focus to meet   shifting organizational and business demands.
  • The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
  • A broad perspective that aligns decisions to organizational objectives and long term consequences of day-to-day activities.
  • The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
  • Additional Requirements:
  • Salary range: Based on experience
  • Hours of Work: 8am-5pm

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