Quality Assurance Specialist

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Revelation Pharma

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2020

💊 Farmacêutico

⚕️ Seguro de Saúde

🤝 B2B

Pharmaceuticals • Healthcare Insurance • B2B

A Revelation Pharma é uma rede nacional de farmácias de manipulação 503A e 503B, dedicada a oferecer preparações e serviços farmacêuticos inovadores e de qualidade. Eles têm como objetivo liderar o setor de farmácias de manipulação, focando em cuidados centrados no paciente e explorando oportunidades de crescimento e colaboração entre farmácias. Sua missão inclui o compromisso de melhorar o negócio farmacêutico e garantir uma transição suave para aqueles que desejam vender ou se associar a farmácias de manipulação respeitáveis.

Descrição

• Maintain proficiency in pharmacy Standard Operating Procedures, USP 795, 797, 800 and all applicable chapters • Stay updated on state, federal, and industry laws and regulations relevant to our operations • Collaborate with management and staff to implement any regulatory changes effectively • Ensure QA/QC tasks are properly documented and maintained throughout pharmacy records for production, product testing and release validation • Participate in investigating deviations, failures, or errors and collaborate with management to identify root causes and implement developed corrective and preventive actions (CAPAs) as needed • Collect and analyze quality data to identify trends and areas for process improvement • Work with third-party laboratories to submit samples according to the established quality test(s) and criteria and follow up on outstanding results • Participate and support pharmacies with internal and external audits • Serve as an assigned trainer to provide training and guidance to pharmacy personnel on quality-related procedures and tasks • Work alongside management to support the corporate goal of instilling a Culture of Excellence, Financial Performance, and Focus on Quality with all pharmacy employees • Assist management with recalls of medications when applicable • Assist pharmacies with board of pharmacy, FDA, and accreditation inspections and responses • Other duties as determined by QA leadership

🎯 Requisitos

• Bachelor’s degree in a related field preferred • Minimum of 3 years of experience in quality assurance or a related field • Strong understanding of quality management principles and procedures • Broad knowledge base of cGMP, FDA, USP, and other Healthcare compliance and applicable regulations and industry standards regarding regulation of compounded preparations • Experience with quality assurance systems and tools • Excellent written and verbal communication skills • Ability to work independently and as part of a team

🏖️ Benefícios

• Health care insurance (medical, dental, vision) • Life Insurance • Supplemental Insurance • PTO • 401K matching • Sick leave