Senior QA Operations Specialist – 1st Shift

Viatris; St. Albans (VT); On-site; USD 55,000 - 105,000; Full time

Job summary

Viatris in St. Albans, Vermont seeks a Senior Specialist, QA Operations on 1st shift to ensure compliance with GMP and quality systems across manufacturing and QA functions.

You will review batch records, release materials, and support investigations while collaborating with cross-functional teams. A Bachelor’s degree with 4 years of GMP experience is required, along with proficiency in MS Word, Excel, Access and Project.

Qualifications

• Bachelor's degree in a GMP environment or related field.
• Fundamental understanding of Quality Systems and cGMP requirements.
• Familiarity with computer software for documentation and data management.

Responsibilities

• Review in-process batch records, finished product batch records, and intermediate analytical records.
• Release intermediate materials.
• Assess operations and process documentation for GMP and SOP compliance.
• Lead evaluation and triage of events, deviations, and unplanned activities affecting processes/materials.
• Ensure deviations are reported and participate in investigations as required.
• Identify improvement opportunities and lead QA improvement projects.

Skills

GMP experience

Quality systems knowledge

Computer literacy

Documentation skills

Education

Bachelor's degree in a relevant field

Tools

MS Word

MS Excel

MS Access

MS Project

Job description

Viatris in St. Albans, Vermont seeks a Senior Specialist, QA Operations on 1st shift to ensure compliance with GMP and quality systems across manufacturing and QA functions.

You will review batch records, release materials, and support investigations while collaborating with cross-functional teams. A Bachelor’s degree with 4 years of GMP experience is required, along with proficiency in MS Word, Excel, Access and Project.