QA MES Specialist
Core
Lead quality activities for Manufacturing Execution Systems (MES) and digital quality tools to ensure compliant production, accurate data, and inspection readiness in a regulated life sciences environment.
Role type
QA MES Specialist
Builds
compliant pharmaceutical and vaccine production processes
Domain
Life Sciences / Pharma Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
MES system configuration, electronic batch record review, deviation investigation, root cause analysis, validation lifecycle (DQ/IQ/OQ/PQ), change control support, GMP/GDP compliance, data integrity principles, supplier quality management
Preferred skills
MES implementation experience, electronic document management systems, formal root cause analysis training, coaching operational teams, technical presentation skills
Technologies
MES, electronic batch records, quality management software, electronic document management systems
Responsibilities
Lead MES quality activities including system configuration reviews and electronic batch record checks; Review MES-generated records for completeness and compliance; Support investigations of deviations linked to MES systems; Partner with validation and IT on MES change control and validation documentation; Coach manufacturing teams on good documentation practices and system use; Maintain inspection-ready MES records and contribute to quality KPI trending; Support readiness for internal and external audits; Manage supplier and third-party quality expectations for MES vendors
Seniority
Mid-level, hands-on IC
