Senior Specialist, QC

Mylan Technologies, Inc.

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:

• Access – Providing high quality trusted medicines regardless of geography or circumstance;

• Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and

• Partnership – Leveraging our collective expertise to connect people to products and services.

Company: Mylan Technologies Inc.

Job title: Senior Specialist, QC Operations

Location: St. Albans, VT

Duties: Write technical documentation for QC (Quality Control) Operations (Protocols, Summary Reports, Test Methods, Specifications and Standard Operating Procedures) related to our pharmaceutical products. Prepare and manage documentation required for post approval QC submissions to health authorities and track the associated change management tasks to completion. Apply knowledge of laboratory techniques and instrumentation in use at Mylan Technologies such as HPLC, GC, Dissolution, physical testing and compendial testing. Serve as project manager for projects led by QC involving cross functional tasks. Represent QC by providing status reports in cross functional projects led by other departments. Gather QC monthly metrics and chair the compendial change control committee. Track QC change controls, including those requiring regulatory submissions. Track QC related Global Quality QAS items. Assist with monthly review of Empower Message Center and Audit Trail. Assist with organizing and tracking equipment qualification and other CAPEX activities and assist with implementation of Global initiatives.

Requirements: Bachelor’s degree or foreign equivalent in Chemistry, Pharmacy, or a related field, and 4 years of experience in the position offered or related, including 4 years of experience with: applying knowledge of various laboratory instrumentation including dissolution baths, HPLC’s, GC’s, FTIR, UV-Vis Spectrophotometers, balances, and pH meter; using scientific software including Empower, LIMS, and Trackwise; applying advanced knowledge of Microsoft Office software including Word and Excel; adhering to Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations and Current Good Manufacturing Practices (cGMPs); and applying knowledge of development of methods for HPLC (Waters HPLC with Empower software), GC (Agilent GC with Empower software) and working with laboratory automation equipment including Mettler Toledo Karl Fisher Titrators with Mettler Toledo KF software.

Submit resume to Mylan Technologies, Inc., a subsidiary of Viatris at https://www.viatris.com/en/careers.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.