Quality Audit Specialist

Job not on LinkedIn

🔥 14 minutes ago

🇺🇸 United States – Remote

💵 $77.5k - $116.2k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Grifols

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1909

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Grifols is a global healthcare company dedicated to improving the health and well-being of people around the world. They focus on the development, production, and distribution of innovative plasma-derived medicines and have a strong commitment to research and development in the pharmaceutical sector. Grifols aims to provide solutions for patients with rare diseases and chronic conditions, contributing significantly to the field of biotechnology and healthcare.

📋 Description

• Execute critical actions enforcing adherence to corporate quality and compliance processes • Conduct quality management systems reviews, data integrity assessments, and risk management assessments • Lead donor centers and shared services through external regulatory and customer inspections • Direct audit planning and response activities • Oversee Plasma Master File updates to ensure donor center compliance • Develop Site Master Files required for external EMA inspections • Deliver expert on-site and remote support during regulatory inspections • Develop, author, and critically review external and internal audit responses and CAPA plans • Coordinate and author final regulatory inspection responses for FDA, EMA, CLIA/COLA, PPTA, State authorities, Health Canada, and internal compliance auditors • Oversee customer audits and provide customer-requested documentation • Conduct QMS assessments evaluating procedural compliance, process robustness, and operational risk • Evaluate procedures and processes against Domestic and European regulations • Identify systemic improvement opportunities through audit-findings analysis • Support Change Requests and author Standard Operating Procedures • Evaluate deviations and analyze tracking and trending data • Represent the department on organizational initiatives and process improvement teams • Travel for audits, meetings, trainings, and center visits

🎯 Requirements

• Bachelor’s degree required • Minimum 5 years experience in quality assurance related field • Must understand the Code of Federal Regulations (CFR) as it applies to Source Plasma • Must know the European Pharmacopoeia (EP) as it applies to Source Plasma and the interaction between the CFR, the EP and the company's SOP manual(s) • Must know CLIA/COLA/PPTA regulations as they apply to Source Plasma and be able to support State required inspections as needed • Ability to write clear, concise, logical responses to regulatory authorities • Strong interpersonal skills • Effective written and verbal communication skills • Critical thinking and attention to detail • Ability to organize tasks and projects effectively • Knowledge of current regulatory standards • Ability to travel 25% or greater if demand requires; position requires 50% and up travel for occasional meetings, trainings or center visits for audits

🏖️ Benefits

• Up to 8% of the company bonus pool • Medical insurance • Dental insurance • Vision insurance • Life insurance • PTO • Paid holidays • Up to 5% 401(K) match • Tuition reimbursement • Opportunities for professional growth and career progression • Family-like culture

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