This job is no longer active.
View similar jobs.
POST DATE 9/2/2016
END DATE 11/1/2016
JOB DESCRIPTIONFOR US, ITS A MISSION At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the worlds 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing whats right, not whats 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. Heres how this role will help:
* Prepare analytical chemistry documents for submission to FDA that include, but not limited to, specifications, procedures, method validation reports, protocols, and certificate of analyses.
* Work closely with Regulatory Affairs to prepare documents using the common technical document format.
* Critically review application, summary, and overview text for quality.
* Approve instrument validation documents.
* Critically evaluate and audit data.
* Approve technical analytical reports and procedures.
* Maintain document control system and file room for laboratory.
* Assist and document laboratory training.
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's degree (or equivalent) and 2-4 years of experience. However, a combination of experience and/or education will be taken into consideration.
* Must possess knowledge of analytical chemistry, pharmaceutical industry practice, and FDA guidance and regulations.
* Must possess strong analytical laboratory skills. Must posses strong communication and reading skills. Basic working knowledge of Microsoft Office and Excel. Must be able to effectively operative a computer based data acquisition system for chromatography. Must be able to multi-task to work on multiple projects at the same time.
* Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group of departments.
* Ability to perform computations such as percentages, ratios, and rates. 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.
* Proficiency in speaking, comprehending, reading and writing English is preferred.
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 30,000 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.
Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran.
Job Posting: Sep 1, 2016, 12:53:47 PM
Unposting Date: Ongoing.