QA Operations Specialist – 1st Shift (GMP & Quality Systems)

5100 Mylan Technologies, Inc.; St. Albans (WV); On-site; USD 55,000 - 105,000; Full time

Job summary

Viatris is seeking a Senior Specialist, QA Operations to help ensure GMP compliance and strong quality systems across manufacturing and analytical processes. The role centers on reviewing batch records, releasing materials, and driving deviations investigations with an emphasis on continuous improvement.

The ideal candidate holds a Bachelor’s degree with 4+ years in a GMP environment and is proficient in MS Word/Excel/Access/Project.

Qualifications

• Bachelor’s degree required; 4 years of GMP-related experience considered equivalent.
• Knowledge of Quality Systems (cGMP, ICH, Pharmacopoeia) and ISO/IPEC standards.
• Proficiency with MS Word, Excel, Access and Project expected.

Responsibilities

• Review in-process batch records, finished product batch records, and intermediate analytical records.
• Release intermediate materials.
• Assess manufacturing operations and process documentation for GMP compliance.
• Lead evaluation and triage of deviations and unplanned activities.
• Ensure deviations are properly reported and investigations are conducted.
• Identify improvement opportunities and lead quality-system projects.

Skills

GMP experience

Quality Systems

MS Word

MS Excel

MS Access

MS Project

Education

Bachelor’s degree

Tools

MS Word

MS Excel

MS Access

MS Project

Job description

Viatris is seeking a Senior Specialist, QA Operations to help ensure GMP compliance and strong quality systems across manufacturing and analytical processes. The role centers on reviewing batch records, releasing materials, and driving deviations investigations with an emphasis on continuous improvement.

The ideal candidate holds a Bachelor’s degree with 4+ years in a GMP environment and is proficient in MS Word/Excel/Access/Project.