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. 

Every day, we rise to the challenge to make a difference and here’s how the Quality Control Technical Specialist role will make an impact:

Key responsibilities for this role include:

Responsible for developing and improving analytical methods and/or new technology.  Conduct (create, execute and report) equipment validation, method validation and research projects. 

Essential Duties and Responsibilities

Identifies and implements new technology, systems, and equipment for QC Laboratories.

Provides technical support and training on new testing, systems, and techniques.

Participates in the preparation, analysis, and control of assigned portion(s) of annual budget of his or her area.

Identifies and implements cost improvements and cost avoidance projects/initiatives,

Identifies and implements process improvement opportunities.

Identifies, configures, validates, and implements LIMS objects and /or structures (Standards and Reagents, Test Methods, Specifications, Instruments)

Responsible for the coordination of activities required from QC in the transfer of new products and or existing products.

Development of Protocols, reports and specifications.

Review/approval of regulatory documentation

Responsible for the coordination of activities required on the Laboratories.

Equipment Calibration, PM and non – routine services

Equipment Validation

Method Validation and / or methods improvements.

Acts as a liaison between technical development and QC during the transfer of new products.

Available to work and provide support during weekends and after working hours.

Interacts with Regulatory Affairs and other Viatris Corporate representatives during the transfer of new products.

The minimum qualifications for this role are:

Education:

Bachelor’s degree in pharmacy, chemistry, natural science or engineering.

Strong Knowledge of GMP’s, validation principles and audit techniques. 

Strong Knowledge of NDA, CMC and DEA/FDA regulations.

Strong Knowledge of compendial methodologies (USP, EP, JP, CH).

Strong Statistical knowledge and experience working with laboratory processes.

Experience/Knowledge:

At least five (5) years of experience in the pharmaceutical industry with similar responsibilities.

Experience handling and/or supporting regulatory inspections.

Knowledge of GMP, NDA, CMC, and DEA/FDA regulations.

 Licenses and Certifications:

Chemist License is required.

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.