Quality Systems Associate

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

Responsabilità Principali:

• Supportare il processo di gestione end-to-end per i documenti GMP e le Procedure Operative Standard (SOP) all'interno del nostro sistema elettronico di gestione dei documenti.
• Rivedere e verificare la documentazione GMP per garantire la piena conformità con le procedure aziendali .
• Supervisionare la distribuzione sicura e tracciata della documentazione ai Clienti, attraverso l'utilizzo di specifici portali, assicurando così che il processo sia conforme alle politiche interne.
• Gestire tutte le attività di archiviazione della documentazione GMP sia internamente che nell'archivio esterno.
• Supportare il team di risposta agli audit fornendo informazioni e documentazione tempestive e accurate relative alla propria area di competenza.

Qualifiche ed Esperienza:

• È preferibile una laurea in una disciplina scientifica (ad es. Biologia, Chimica, Biotecnologia, Farmacia).
• Almeno 1 anno di esperienza in un ruolo di controllo della documentazione o di assicurazione qualità in un ambiente regolamentato GMP (industria farmaceutica o biotecnologica).
• Conoscenza degli standard GMP .
• Competenza nell'uso di Sistemi di Gestione Elettronica dei Documenti (come TrackWise) e Office
• Attenzione ai dettagli e capacità relazionali
• Buona conoscenza della lingua inglese

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. 

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.