Change Control Specialist - United States
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- 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.
- 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.
- 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.