Job Details

Senior-LIMS-Specialist

Company name
Mylan Inc

Location
Morgantown, WV

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['USA-WV-Morgantown','Mylan Pharmaceuticals Inc.','Senior LIMS Specialist','17001332','!*!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:

Provide Tier 1 support to end users of the Quality portion of the application, including answering technical and process related questions, troubleshooting errors, performing root cause analysis.

Elevate issues to senior team members and/or Laboratory Informatics IT COE as necessary.

Work as systems support for the LabWare LIMS application and the LabWare LIMS Master Data process.

Assess incoming requests, documents, and other dynamic business data for LIMS Impact.

Once impact has been evaluated, determine proper configuration accounting for sampling, testing, trending and other interconnected portions of the application.  

Build the LIMS product specifications by adding correct tests, applying the correct limits and setting configuration flags appropriately.

Create and/or modify additional LIMS files, tables or counters as necessary to complete full implementation of builds and updates.

Support the site change control process with regards to ensuring the integrity of the LabWare LIMS system.

Build LIMS Product Specifications, Spec Codes, and other tables for and non-standard testing required by the laboratory, to support submissions, investigations and CAPAs.

Revise and maintain supporting laboratory systems controlled in LIMS such as: Certified Testing, Proven Acceptable Range and In House limits, Stability, Scheduling, and Metrics Reporting.

Provide peer review of modifications to LIMS and apply updates to samples accordingly.

Set documents effective in DCM Operations cabinet Product folder.

Perform end user/super-user training as required.

Assist with site implementation and other project activities, including but not limited to Business process assessment, Risk mitigation and configuration determination.

Work with site and LIMS management in the creation of written Business Requirements and test scripts for validation.

Conduct Verification and Validation testing for new analyses and new functionality as required.

Travel may be required, as necessary.','!*!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) in Chemistry, Computer Science or related scientific discipline and 2-4 years of experience.  4-6 years of experience preferred. However, a combination of experience and/or education will be taken into consideration.

Must possess knowledge of cGMPs, 21 CFR, ICH and FDA requirements.

Must be able to understand and adhere to government regulations, and company and departmental policies and procedures.

Familiarity with Mylan product testing methods and specifications a plus.

Must possess good communication, technical writing and documentation, reading, comprehension, time management, and computer skills including knowledge of Microsoft Excel, Word, PowerPoint, and Outlook.

Must be accurate, detail oriented, and possess the ability to multi-task.

Excellent organizational and deductive reasoning skills are essential.

Must be able to work and interact well with other employees at all levels.

Proficiency in speaking, comprehending, reading and writing English is required.

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.

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. ','','Full-time','','','Oct 10, 2017','Ongoing','Senior LIMS Specialist

Company info

Mylan Inc
Website : http://www.mylan.com

Company Profile
Our history, our mission and our values tell the story of who we are as a company. We began as a pharmaceutical distributor, providing products to customers in smaller communities.

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