Senior Specialist, QC Technical Services
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world’s largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information, please visit
We are currently seeking a Senior Specialist, QC Technical Services at our Caguas, Puerto Rico location. This person will assist the Analytical Method Transfer (AMT) and Validation group in the preparation, execution, troubleshooting, information gathering and establishing contacts for the achievement of the area projects. This includes R&D, business continuity projects, new material sources, products transfer, technology transfer to external laboratories and cleaning validation program.
Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Support the Analytical Method Transfer and Validation group in achieving the assigned projects on a timely manner. Principal liaison with the R&D group, donor sites, third parties on providing and obtaining information of the Validation Activities being performed such as, Method Transfer or Analytical Method Validation.
Participate in meetings related to Analytical Method Transfer and Validation Group responsibilities. Asses in advance all the required equipment and material to support the AMT & Validation Manager on the coordination of the activities of the area.
Resolve technical situations, establishing technical contact, searching on literature or by contacting other Mylan technical groups.
Maintain adequate flow of information within the group of the status of the projects.
Maintain relationship with the other laboratories for the required coordination of equipment or personnel.
Prepare and/or approve Analytical Protocols and Reports (e.g. Analytical Method Validation and Analytical Method Transfer Protocols, Reports).
Evaluate and Approve Compendial Changes and/or Analytical Duties as part of Compendial Changes and/or Updates.
Promote the continuous improvement initiatives. Sponsors active communications with the external and internal customers in order to maintain high quality service.
Perform analytical testing, as well as, analytical data review.
Perform other duties as assigned.
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 basic statistics, different pharmacopeias, Corporate and Regulatory Agencies Policies, as well as Federal Food Drug, and Cosmetic Act. Must have also knowledge of operational excellence strategies required. Must possess strong knowledge in Analytical Method Validation and Analytical Method Development. Knowledge and skills in supervision. Strong Experience in laboratory Instrumentation such as, HPLC, GC, UV-VIS among others. Must possess knowledge of different pharmacopeias such as, USP, EP and JP.
Must possess strong communication and organizational skills. Experience with Microsoft Office Suite (Word, Excel, Access and PowerPoint), LIMS, SAP and TrackWise is required.
Must possess PR Chemist License.
At Mylan, we are not satisfied with anything less than being the best. As one of the world's leading generics and specialty pharmaceutical companies, the key to our success starts with a relentless drive to set the highest industry standards in everything we do. It takes exceptional people working together to achieve excellence. As a team, we earn our customers’ trust and loyalty by placing a high premium on always doing the right things in the right way.
Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. Mylan is an Equal Opportunity Employer, M/F/D/V.
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