Senior Specialist, QA Operations – 5th Shift

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 Operations role will make an impact:

Requirements

• Minimum of a bachelor’s degree (or equivalent)
• 4+ years of relevant experience
• fundamental understanding of Quality Systems, Quality Control laboratory, and cGMP
• A combination of experience and/or education will be taken into consideration

Responsibilities

• Review in-process batch records finished product batch records (Pharm, and/or MPD), and intermediate analytical records.
• Release intermediate materials.
• Assess the manufacturing operations and process documentation for compliance to GMP’s and Standard Operating Procedures.
• Leads the evaluation and triage of events, deviations, and unplanned activities that impact processes and/or materials.
• Assure deviations are appropriately reported.
• Participate in investigations of deviations, as required.
• Identifies improvement opportunities and participates on project teams geared toward continuous improvements of the quality system.
• Fulfill role as QA Subject Matter Expert in specific elements of the manufacturing process.
• Maintain QA retain inventory and perform annual retain inspections.
• Conduct training activities related to QA operations and quality systems.
• Attends training classes and seminars as needed.

Benefits

• competitive salaries
• benefits
• 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