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:
Review and approve analytical method transfer protocols, reports, and transfer waivers in support of new launch products from Research and Development as well as analytical method transfer projects from other Mylan sites/affiliates. Interface with R&D Chemistry, Quality Technical Services, and Quality Control teams to review analytical specifications, test methods, and method validation documents.
Perform Pharmacopial Forum (PF), USP, EP/BP, JP and supplement review in order to maintain regulatory compliance within the QC Laboratory.
Provide support for tracking and responding to Health Authority correspondences (ie, Compete Response Letters, Information Requests, etc).
Initiate and review all change controls supporting the QC Laboratory for regulatory submission and product development.
Interact with various work groups to ensure accurate change control submissions.
Evaluate and assess purchasing change controls.
Assist in SOP revisions and review.
Mentor Specialists on the Launch Transfer team and author/review/approve procedures in support of continuous improvement activities.
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 basic knowledge of HPLC, GC, TLC, Wet Chemistry, Dissolution, and Microbiology analysis in the pharmaceutical industry. Must possess knowledge of SOPs. Knowledge of auditing protocols and processes. Understanding of FDA regulations, regulatory requirements and cGMP compliance. Demonstrate instructional skills capable of effectively communicating knowledge and expertise.
Must possess excellent communication, technical writing and documentation, reading, comprehension, organization, time management and computer skills including knowledge of Excel, Word, and PowerPoint. Must have working knowledge of eSOP and Documentum. Must be accurate, detail oriented and possess the ability to multi-task. Must possess team-building skills and must be able to work with different management levels. Excellent interpersonal skills and time management required.
Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with managers or directors and communicate ambiguous concepts. Ability to present to groups across the organization.
Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals. Ability to compute rate, ratio and percent and to interpret graphs and data sets.
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.
Normal office work situation with occasional time spent in the laboratory. Works independently and/or closely with others on projects.
Proficiency in speaking, comprehending, reading and writing English is preferred.
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.