What are the responsibilities and job description for the Senior Specialist, QA Quality Systems position at Viatris?
Senior Specialist, QA Quality Systems
locations
St. Albans, Vermont, USA
time type
Full time
posted on
Posted 15 Days Ago
job requisition id
R5667940
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.
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:
Key responsibilities for this role include:
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.
The minimum qualifications for this role are:
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.
Exact compensation may vary based on skills, experience, and location. The salary range for this position is $55,000.00 - $105,000.00 USD.
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.
Salary : $55,000 - $105,000