Associate QA Operations Expert - Release
Core
Ensure compliant and timely release of raw materials, bulk products, packaged goods, sterilizations, and imported batches while supporting investigations and maintaining process robustness.
Role type
Associate QA Operations Expert (Release)
Builds
Pharmaceutical product batches ready for patient distribution
Domain
Pharmaceutical manufacturing and regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Good Manufacturing Practices (GMP), Quality Assurance (QA), Quality Compliance, Regulatory Compliance, Standard Operating Procedure (SOP), Statistical Process Control (SPC), Internal Quality Auditing, Managing Ambiguity, Operational Excellence, Quality Management Systems (QMS), Data Integrity
Preferred skills
Qualified Person (QP) experience
Technologies
Digital documentation systems
Responsibilities
Review and assess non-conformities, support investigations, and define effective CAPAs; Monitor file and batch status versus targets and follow up on problem or priority lots; Provide clear explanations of QA release documentation during internal and external audits; Keep assigned procedures accurate, updated, and aligned with evolving operational requirements.
Seniority
Associate, hands-on IC
