Principal Analytical QA Specialist, Drug Substance

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🕒 vor 16 Tagen

🇺🇸 Vereinigte Staaten – Remote

💵 $150.000 - $190.000 / Jahr

⏰ Vollzeit

🔴 Experte

🔧 QA-Ingenieur (Qualitätssicherung)

🦅 H1B-Visum-Sponsor

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Loyal

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

🏥 Gesundheitswesen

💼 Beratung

📦 Logistik

Healthcare • Consulting • Logistics

Loyal ist eine führende, ganzheitliche digitale Gesundheitsplattform, die darauf ausgelegt ist, Versorgungsschnittstellen für Patienten und Anbieter zu vereinen. Mit dem Ziel, das Gesundheitswesen durch Technologie zu verbessern, integriert die Plattform maschinelles Lernen, natürliche Sprachverarbeitung und branchenführende Datenmanagementlösungen. Loyal bietet Werkzeuge zur Verwaltung von Anbietern und Standortdaten, digitalem Engagement, Optimierung der Versorgungssuche, Patienten-Selbstterminierung, KI-gesteuerten Gesprächen, CRM-Kampagnen, Terminerinnerungen und Reputationsmanagement. Sie hilft Gesundheitssystemen, ihre Abläufe zu transformieren, die Patientenbindung zu verbessern und Gesundheitsergebnisse zu optimieren, indem sie nahtlosen Zugang zu Versorgungsinformationen und -prozessen gewährleistet.

Beschreibung

• Oversee all aspects of drug manufacture and testing through clinical development and into commercial phase. • Provide Quality oversight for analytical method development, qualification, validation, transfer, release testing, and stability programs supporting drug substance and drug product development. • Support establishment of phase-appropriate specifications, stability-indicating methods, and control strategies aligned with regulatory expectations. • Review and approve validation protocols, raw data, and reports (for test method, process, cleaning, etc.). • Manage the batch release program by reviewing executed documentation, raw data, quality events (change controls, deviations, CAPAs, OOS/OOT investigations, risk assessments) and product disposition decisions. • Review and approve master and executed batch records, analytical raw data, stability protocols, reports and data, and other documents to enable drug substance and final drug product release and ongoing evaluation ensuring batches are compliant with cGMP requirements. • Lead or support quality event resolution investigations (e.g., OOS/OOT results, deviations), ensuring root cause analysis, CAPA development, and timely closure. • Support inspection readiness, audit programs, risk management, quality metrics reporting, Annual Product Review (APR) and product quality processes, Field Alert Report (FAR), product withdrawal, and product recall process. • Perform data integrity and compliance assessments including review against source documentation for regulatory submissions. • Maintain effective communication with Contract Development and Manufacturing Organizations (CDMOs) and Contract Testing Laboratories (CTLs) to ensure Quality objectives are achieved in accordance with project timelines. • Maintain awareness of evolving veterinary pharmaceutical regulations and ensure compliance strategies are updated accordingly.

🎯 Anforderungen

• B.S./M.S. degree in a scientific discipline (Pharmaceutical Sciences, Chemistry, Veterinary Science, or related field) • Minimum 12 years of relevant pharmaceutical industry experience, with at least 6 years in GxP QA roles. • Strong knowledge of FDA CVM regulations, cGMP, and VICH guidelines applicable to veterinary products • In-depth working knowledge of drug substance development and manufacturing, analytical method development, validation, release testing, stability programs, and quality systems. • Experience managing CDMOs and collaborating effectively across cross-functional teams. • Capable of working successfully in a team/matrix environment and independently, as required. • Ability to meet deadlines, demonstrate efficient and effective use of time, and handle multiple assignments simultaneously. • Ability to convey both written and verbal information effectively and efficiently. • Demonstrated ability to follow procedures and perform assignments with a high degree of accuracy and careful attention to detail. • Willingness to travel (10%).

🏖️ Vorteile

• Full-coverage health insurance — medical, dental and vision — for you and your dependents • $1,000 home office equipment stipend • $1,200/year learning budget for books, courses, etc. • $250/month wellness budget for gym, cleaners, spa, food, etc. • All 3-day weekends are turned into 4-day weekends 🎉 • Unlimited vacation and paid holidays • Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶 • Competitive salary • Company equity options grant for new hires