Specialist QA – cGMP Compliance & Environmental Monitoring

About the role

The Specialist QA supports the site Quality Assurance program, ensuring compliance with cGMP requirements, regulatory standards, and internal quality systems. Working under minimal supervision, the role oversees manufacturing, environmental monitoring, critical utilities, validation, and drives continuous improvement.

Key responsibilities

• Review and approve product master plans, process validation protocols, validation reports, work orders, EMS/BMS alarms, non‑conformance investigations, CAPA records, and change controls.
• Provide lot disposition, authorize shipments, and lead investigations, site audits, and quality program procedures.
• Serve as QA designee on local CCRB, represent QA on NPI teams, and participate in incident triage, automation, facilities, and environmental programs.
• Generate and analyze EM and Critical Utilities trend reports, lead risk assessments, and ensure compliance with Annex 1, FDA guidance, ISO‑14644‑1, and USP standards.

Required profile

• 10+ years in the biopharmaceutical industry with at least 5 years in Quality Assurance.
• Strong knowledge of cGMP, validation, process development, and GMP manufacturing.
• Ability to lead cross‑functional teams, influence stakeholders, and communicate effectively in English and Spanish.
• Demonstrated experience interacting with regulatory agencies and supporting internal/external audits.

Required skills

• cGMP compliance and validation expertise.
• Environmental monitoring (EM) and critical utilities (CU) monitoring.
• Proficiency with Veeva, Spotfire, LIMS, Maximo, Microsoft Office, Smartsheets, and data visualization tools.
• Statistical analysis and AI/data‑analytics platforms for trend interpretation.