Senior Analyst, Quality Trust & Compliance

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🕒 il y a 6 mois

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟠 Senior

🚔 Conformité

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Endpoint Clinical

Site WebLinkedInTous les Emplois

501 - 1000 employés

🧬 Biotechnologie

⚕️ Assurance santé

💊 Pharmaceutique

💰 €1 700 000 Debt Financing en 2010-03

Biotechnology • Healthcare Insurance • Pharmaceuticals

Endpoint Clinical est un leader des solutions de gestion de la randomisation et de l'approvisionnement pour les essais cliniques (RTSM), spécialisé dans la transformation et l'accélération des essais cliniques avec transparence, confiance et innovation. Leur technologie améliore l'efficacité et la précision de la randomisation des patients et de la gestion de l'approvisionnement clinique. Soutenant une gamme de domaines thérapeutiques, Endpoint Clinical offre des solutions sur mesure pour les grands sponsors pharmaceutiques, les sponsors de petite à moyenne taille et les organisations de recherche sous contrat (CRO). Leur technologie avancée et configurable optimise les processus d'essai, améliore la gestion de l'approvisionnement en médicaments et améliore l'expérience du site, garantissant que les essais mondiaux restent sur la bonne voie.

Description

• A primary point of contact for resourcing and guidance of product release team • Provide QTC review and approval of in-process tasks related to product and/or service provision • Develop and oversee onboarding and training of Analysts on QTC product release team • Act as subject matter expert and point of contact for Software Development Life Cycle process • Develop, write, and revise controlled Validation Deliverables and in continuous improvement efforts and procedures and practices related to product release • Provide ad hoc training to Operations staff on compliance procedures associated with product release • Responsible to perform the following QTC product release duties • Generate, perform review, and maintain records of Validation Deliverables documentation and ensure compliance to procedures and processes. • Maintain validation documentation in QMS according with company procedures • Provide support to operations staff to develop, write, and revise controlled Validation Deliverables. • Act as primary QTC representative and resource to Operations staff with regards to product release • Maintain validation documentation in QMS according with company procedures • Assist in preparation, review, and maintenance of reports for identified product events • Participate in Root Cause Analysis meetings with the Operational staff and provide input on the identification and documentation of Corrective Actions/ Preventive Actions for events of discrepancy or failure of released product • Assist CAPA team in completion of outstanding CAPA items with the appropriate stakeholders as it relates to product release. • Support the Governance unit in preparation for External Audits related to product release. • Perform QMS documentation Quality Control (QC) reviews on controlled documents such as SOPs, Work Instructions and Policies as well as provide feedback to key stakeholders as needed.

🎯 Exigences

• M.S. degree and minimum 2 years of related experience OR · BS/BA degree and minimum 4 years of related experience • Certification in Quality Assurance or Regulatory Affairs preferred • Minimum 2-4 years of relevant working experience within a regulated environment · Substantial working knowledge of FDA regulations (21 CFR Part 11, EU Annex 11) regulations and current industry best practices · Knowledge of U.S. and international regulatory standards and guidelines · Relevant experience preferably in the clinical trial industry, IRT, or CRO experience is highly desired. · Experience with a QMS and LMS preferred

🏖️ Avantages

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