Just Evotec Biologics
biopharmaceutical/Pharmaceutical
QASpecialist
“QA Specialist at Just Evotec Biologics. Skills: QA Operations, GMP manufacturing, cGMP compliance. execution of day-to-day QA responsibilities for GMP manufacturing. building and enhancing the quality assurance systems”
What You'll Achieve.
ensure compliance with cGMPs and internal procedures; ensure compliance in Manufacturing operations; alert senior management of significant quality, compliance, supply, and safety risks
Industry & Context.
solving complex problems; find creative solutions
Site Based, Redmond, WA (onsite), Shifts: Days 07: 00 till 16: 00, Tue to Sat or Sun to Thurs
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
ensure compliance with cGMPs and internal procedures
Review executed Manufacturing Batch Records
Execute compliance walkthrough of the Manufacturing floor and other assigned areas
Participate in the training of new or junior staff
Partner with Manufacturing to ensure compliance in Manufacturing operations
Triage Manufacturing events and support event investigations
Review and approve Master Batch Records and other supporting documents
Support internal and client audits
Execute process performance and product quality monitoring programs
Alert senior management of significant quality
How You'll Work.
Team & Collaboration
works both independently and collaboratively with Manufacturing, Quality and Facilities staff; Partner with Manufacturing to ensure compliance in Manufacturing operations; collaborate and communicate cross-functionally
Communication Scope
Ability to collaborate and communicate cross-functionally
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