QA Specialist overseeing quality assurance responsibilities for GMP manufacturing. Collaborating with teams on quality events and regulatory compliance in a biopharmaceutical setting.
Responsibilities
execution of day-to-day QA responsibilities for GMP manufacturing
building and enhancing the quality assurance systems
review and assess all quality events of eQMS (Deviations, Change Control, CAPA, Risk Assessment, Management Review, Complaint Investigation, Product Quality Review etc.)
provide inputs and reviews on communication as to the status of deliverables to customers, management, and stakeholders
develop, review, and deliver training regarding QMS process or system changes
support QA QMS in internal and external client audits and regulatory inspections
monitor and review effectiveness for QMS through trending, analysis, and metrics; report to top management and G-QMS on the performance of the KPIs and identify opportunities for continuous improvement
alert senior management of significant quality, compliance, supply, and safety risks
Requirements
Bachelor’s degree in biological or engineering science
Minimum of 2 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment
Ability to collaborate and communicate cross-functionally
Proven attention to detail.
Benefits
discretionary annual bonus
comprehensive benefits to include Medical, Dental and Vision
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