JustEvotec Biologics
QASpecialist,SiteBased,Redmond,WA
“QA Specialist, Site Based, Redmond, WA at JustEvotec Biologics. Skills: Quality Management Systems (QMS), cGMP compliance, Cross-functional coordination, Vendor/stakeholder management, Operational metrics, Resource planning, Continuous improvement. Execution of day-to-day QA responsibilities for GMP manufacturing. Building and enhancing the quality assurance systems”
What You'll Achieve.
Assure compliance with regulatory and Just-Evotec Global Quality Management Systems (G-QMS) requirements; Monitor and review effectiveness for QMS through trending, analysis, and report to top management and G-QMS on the performance of the KPIs; Identify opportunities for continuous improvement
Industry & Context.
Solving complex problems; Finding creative solutions
What They're Looking For.
Must Have
Bachelor’s degree in biological or engineering science, Minimum of 3 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment, Ability to collaborate and communicate cross-functionally, Proven attention to detail
What You'll Do.
Execution of day-to-day QA responsibilities for GMP manufacturing
Building and enhancing the quality assurance systems
Ensuring compliance with cGMPs and internal procedures
Review and assess all quality events of eQMS (Deviations
Complaint Investigation
Product Quality Review etc.) to assure compliance with regulatory and Just-Evotec Global Quality Management Systems (G-QMS) requirements
Provide inputs and reviews on communication as to the status of deliverables to customers
and deliver training regarding QMS process or system changes
Support QA QMS in internal and external client audits and regulatory inspections (including but not limited to SME for QMS processes and individual records)
Monitor and review effectiveness for QMS through trending
and report to top management and G-QMS on the performance of the KPIs and identify opportunities for continuous improvement
How You'll Work.
Team & Collaboration
Collaborate and communicate cross-functionally; Works both independently and collaboratively with Manufacturing, Quality and Facilities staff; Provide inputs and reviews on communication as to the status of deliverables to customers, management, and stakeholders; Support QA QMS in internal and external client audits and regulatory inspections
Communication Scope
Ability to collaborate and communicate cross-functionally; Provide inputs and reviews on communication as to the status of deliverables to customers, management, and stakeholders
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