Lead QA Quality Systems Specialist GMP Excellence

1100 Mylan Pharmaceuticals Inc.; St. Albans (VT); On-site; USD 66,000 - 127,000; Full time

Job summary

Mylan Technologies, Inc. in St. Albans, VT is seeking a Lead Specialist QA Quality Systems for the 1st shift. This role focuses on investigations, CAPA, deviation triage, and continuous improvement within the site's Quality System.

Responsibilities include leading cross-functional problem solving, preparing APRs/PQRs, site metrics, and supporting external audits and Health Authority inspections.

Qualifications

• BS degree and 10+ years of relevant experience in a GMP environment.
• Working knowledge of cGMP and Quality Systems.
• Understanding of change control and regulatory expectations in change management.

Responsibilities

• Lead complex investigations, trends, propose CAPA actions and prepare investigation reports.
• Represent QA in triage of deviations, ensuring proper evaluation and containment actions.
• Lead cross-functional structured problem solving to support investigations.
• Compile/analyze investigation information for APRs, PQRs, Site Metrics and leadership presentations.
• Provide oversight for site quality system elements and continuous improvement projects.
• Support external audits and Health Authority inspections.

Skills

Statistical analysis

Advanced mathematical calculations

Strong communication skills

Technical writing

Education

BS degree

Job description

Mylan Technologies, Inc. in St. Albans, VT is seeking a Lead Specialist QA Quality Systems for the 1st shift. This role focuses on investigations, CAPA, deviation triage, and continuous improvement within the site's Quality System.

Responsibilities include leading cross-functional problem solving, preparing APRs/PQRs, site metrics, and supporting external audits and Health Authority inspections.