QA Operations Lead - GMP Compliance & Process Excellence

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

Job summary

Viatris is hiring a Senior Specialist, QA Operations to review batch records, release materials and ensure GMP compliance. The role involves leading deviation investigations, driving continuous improvement, and training staff in QA systems.

Requires a Bachelor’s degree and 4 years in a GMP environment with knowledge of cGMP/ICH standards. The position is based in the United States (Vermont) with on-site responsibilities and opportunities to contribute to quality systems and training programs

Qualifications

• Bachelor’s degree with 4 years of relevant GMP experience or equivalent combination of education/experience.
• General knowledge of Quality systems for Pharmaceutical Industry (cGMP, ICH, Pharmacopoeia) and Medical Products (ISO, IPEC).
• Computer proficiency with MS Word, Excel, Access and Project.

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 events, deviations, and unplanned activities.
• Ensure deviations are reported; participate in investigations as required.
• Identify improvement opportunities and lead QA projects for continuous quality system improvement.
• Serve as QA Subject Matter Expert in elements of the manufacturing process.
• Maintain QA retain inventory and perform annual retain inspections.
• Conduct QA training and develop SOPs, QFs and training modules.

Education

Bachelor’s degree in a GMP/QA related field

Tools

MS Word

MS Excel

MS Access

MS Project

Job description

Viatris is hiring a Senior Specialist, QA Operations to review batch records, release materials and ensure GMP compliance. The role involves leading deviation investigations, driving continuous improvement, and training staff in QA systems.

Requires a Bachelor’s degree and 4 years in a GMP environment with knowledge of cGMP/ICH standards. The position is based in the United States (Vermont) with on-site responsibilities and opportunities to contribute to quality systems and training programs