Stability Specialist

Employment Type

: Full-Time

Industry

: Miscellaneous



For Us, It's

 A Mission At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world's 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing what's right, not what's easy. If you are a doer and have a passion for serving others, we want to talk to you. Make a Difference At Mylan, each person has the ability to make a difference. From the providers who sell and market our products, to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here's how this role will help:
  • Create and maintain product stability studies in LIMS and legacy systems as appropriate.
  • Create stability protocols in DCM.
  • Review and approve stability data .
  • Maintain data tables and graphs for legacy studies.
  • Assist in the process of sample set-down and execution of routine daily activities such as sample pull and delivery and chamber maintenance.
  • Assist in performing controlled substance inventories per DEA regulations. Support controlled substance investigations into shortages and overages when required.
  • Provide stability data and analysis as requested to support regulatory submissions and investigations.
  • Prepare stability reports and documents to support Annual Reports and Product Quality Reviews as needed.
  • Make Our Values Your Values

    Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position:

  • Minimum of a Bachelor of Science degree and 0 - 2 years of laboratory or stability experience is required. However, a combination of experience and/or education will be taken into consideration.
  • Must possess knowledge of analytical chemistry techniques utilized in QC and R&D laboratories. Requires mathematical skills and familiarity with basic statistical techniques such as regression. Requires understanding of FDA and European cGMP regulations, ICH guidance documents, and DEA regulations.
  • Must possess proficiency in Microsoft Office products including Word and Excel. Requires attention to detail and the ability to communicate well both through writing and speaking. Must possess aptitude and ability to quickly learn complex software programs such as LIMS and Minitab. Prior experience with LIMS and/or Minitab is a plus.
  • Ability to read and interpret general business documents. Ability to write routine reports and general business correspondence. Ability to work with peers and communicate basic concepts.
  • Ability to add, subtract, multiply and divide. Ability to perform basic statistical calculations such as mean and standard deviation. Comfortable with the concepts of regression. Prior experience with more advanced statistics is a plus.
  • Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
  • Why Mylan?

    If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 35,000 worldwide, we can make a difference. We encourage you to visit Mylan.com to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care.


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