Senior Specialist, QA Quality Systems

Viatris • St. Albans, VT

1d • $55,000 - $105,000

About The Position

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 Senior Specialist, QA Quality Systems role will make an impact:

Requirements

• Minimum of a Bachelor’s degree, 4+ years of relevant experience, preferably in a Pharmaceutical cGMP environment. A combination of experience and/or education will be taken into consideration.
• Must possess a fundamental understanding of Quality Systems and cGMP.
• Must possess knowledge and familiarity with computers and various software such as MS Word, Excel, and MS Project.

Responsibilities

• Performs tasks associated with the processes and activities supporting the operation of MTI’s Quality Systems.
• Lead moderate/complex investigations, trends, propose associated CAPA actions and prepare associated investigation reports.
• Performs review/close out and effectiveness checks of completed CAPA, in accordance with the approved CAPA.
• Owns and executes department CAPA , as assigned.
• Authors new or revised site procedures as assigned.
• Participate on project teams as assigned.
• Prepares and provides training in related to MTI’s quality system investigations, complaints, change control, site procedures and cGMP as assigned.
• Prepares presentations and leads meeting as required
• Supports external Audits (i.e. Corporate, Vendor, ISO etc.) and Health Authority Inspections.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level