
Specialist Qa
hace 3 semanas
Job Description
• Foundation in quality assurance roles focused in Quality Management Systems and GMP documentation (must have)
• Support development of new equipment/technology introduction projects, preferably within Packaging Area (must have)
• Be knowledgeable about compliance and regulatory aspects for equipment validation, operation and maintenance (must have)
• Be knowledgeable about compliance and regulatory aspects of Devices /Combination products industry (preferable)
• Support Readiness of manufacturing operations documents/systems to support new product/process/devices introduction, including but not limited to SOPs, Equipment Commissioning & Qualification (protocols, testing, reports, etc.)
documents and provide deliveries in a timely manner (must have)
• Effectively collaborate with key customers and support groups (e.g.
Manufacturing staff, Process Owners, Quality, Process Development, System Owners/Equipment Maintenance, etc.).
• Team-oriented, with a focus on achieving team goals (must have)
• Strong change management and project management skills (must have)
• Expertise in MS Office (Word, Excel, PowerPoint, MS Teams) (must have)
• Expertise in computer applications such as Veeva, CMMS (Maximo), Trackwise, etc (preferrable) Requirements Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.
Scientific and/or Engineering background
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