Stability Operations Specialist - GMP & Compliance

Viatris; Morgantown (WV); On-site; USD 39,000 - 88,000; Full time

Benefits offered by this job

Competitive salary

Inclusive environment

Job summary

Viatris in Morgantown, WV is seeking a Stability/QA Lab Associate to support GMP-scale stability studies, perform daily sample pulls for ANDA submissions, and manage records across multiple sites. You will maintain the LIMS and Records Management System, ensure proper labeling and logging, and assist with training and routine lab duties.

The role requires 2-4 years of experience, strong communication skills, and the ability to work autonomously in a fast-paced environment.

Qualifications

• Minimum of 2-4 years of experience or equivalent combination of experience and education.
• Ability to read and interpret general business documents and write routine reports.
• Good communication and interpersonal skills; ability to multi-task.
• Proficiency with English reading, writing and comprehension.

Responsibilities

• Perform set down of all stability studies for GMP scale up lots and experimental lots.
• Perform daily sample stability pulls to support ANDA submissions.
• Maintain all inventory, labeling, tracking, and logging within the LIMS database for scale-up and stability samples.
• Maintain labeling, tracking, and logging within the Records Management System for appropriate documents and files.
• Order, release, audit, and maintain Laboratory Workbooks.
• Perform chamber chart monitoring including weekly changing of all charts in multiple locations.
• Perform duties within the Research and Development Operations Stability Rooms and File Rooms, as needed.
• Perform training for the Research and Development Operations Stability Rooms and File Rooms, as needed.
• Perform other duties as assigned.

Job description

Viatris in Morgantown, WV is seeking a Stability/QA Lab Associate to support GMP-scale stability studies, perform daily sample pulls for ANDA submissions, and manage records across multiple sites. You will maintain the LIMS and Records Management System, ensure proper labeling and logging, and assist with training and routine lab duties.

The role requires 2-4 years of experience, strong communication skills, and the ability to work autonomously in a fast-paced environment.