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Change Control Specialist - United States  

Company managed [?] Still accepting applications

Posted on : 29 May 2017

Project Description

Job Description 
  • Our company is  a leading global healthcare company, delivers value to its customers and consumers by providing Quality Affordable Healthcare Products
  •  Founded in 1887 as a packager of home remedies, our company  has built a unique business model that is best described as the convergence of a fast-moving consumer goods company, a high-quality pharmaceutical manufacturing organization and a world-class supply chain network. 
  • Our company  is the world's largest manufacturer of over-the-counter ("OTC") healthcare products and supplier of infant formulas for the store brand market. 
  • The Company also is a leading provider of branded OTC products throughout Europe and the U.S., as well as a leading producer of "extended topical" prescription drugs.Our company sells its products primarily in North America and Europe, as well as in other markets, including Australia, Israel and China. 
  • Joining us  means joining a team that is driven and excited to make healthcare products more affordable around the globe. 
  •  Our products improve our consumer’s quality of life – let us improve the quality of your career.    


Role:
  • This position will provide technical support to the business areas relative to QA review of change control documentation for equipment, material and process related changes. 
  • This position will review the current equipment, process, packaging, materials and master formulas with change initiators and other stakeholders to determine requirements that must be implemented. 
  • The Change Control Specialist will review and coordinate change control documentation and, as necessary, assist with the writing of change controls and supporting documentation. 
  • This position will participate in Quality driven initiatives to support continuous improvement. 



Required Experience 
         
  • Bachelor’s degree required. A degree in Engineering, Chemistry, or a related scientific field preferred. In lieu of a degree consideration may be given to those who hold 6+ years of progressively responsible and relevant work experience. 
  • Experience with compiling and analyzing technical data and information required. 
  • The ability to work with TrackWise software is required. 
  • A background in Quality Assurance or Quality Control with 2-4 years of experience preferred. 
  • Excellent organization skills and the ability to prioritize and process multiple tasks are required. 
  • This candidate will have a good understanding of FDA and cGMP regulatory requirements and a clear understanding of change control and quality systems. 
  • Excellent communication skills are necessary, including well developed verbal and written communication skills and good interpersonal skills. 
  • Attention to detail and the ability to follow through on projects involving multiple departments are also necessary.