Senior Quality Assurance Specialist
Há 7 dias
Senior Quality Assurance Specialist
LATAM Remote
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us
Primary Purpose
The Senior Quality Assurance (QA) Specialist is a member of the Quality Assurance department and assists QA management in continual management of the Quality Management System (QMS), including conducting audits (internal and vendor), leading client audits, supporting regulatory inspections, and other activities such as issue management and controlled document management. This individual works with project and department leaders to assist projects and departments with adherence to applicable regulations, industry standards, and project requirements. The Senior QA Specialist mentors less experienced team members.
Responsibilities- Conducts internal audits of projects, processes, clinical sites, deliverables, and departments of moderate to complex scope, requiring an in-depth evaluation and capacity to synthesize and apply information from one task or audit to another.
- Reviews documentation for accuracy and compliance (e.g., training records, CAPAs, quality incidents, audit reports, Computer System validation package, etc.).
- Reviews and tracks non-compliances, deviations, and CAPAs.
- Leads supplier/vendor qualification and evaluation.
- Leads client audits and regulatory inspections.
- Leads or participates in process improvement projects.
- Assists in or creates audit schedules for one or more portions of the QMS.
- Writes and reviews Quality SOPs and policies.
- Conducts trainings on quality topics, as assigned.
- As a subject matter expert, provides guidance or mentors and trains less experienced team members.
- May have day-to-day oversight of some QMS activities or functions.
- Represents the QA department at meetings or events with nominal assistance or oversight from Quality Management.
- May contribute to solutions for corporate and global QA initiatives and tasks.
- Performs other duties as assigned.
- Bachelor's degree in Life Sciences or a related scientific field and 4- 6 years related experience.
- Experience working in a regulated environment (e.g., GxP, ISO)
- Knowledge and understanding of GxP regulatory requirements and implementation (FDA, EU, ICH and country specific regulations and relevant guidance)
- In addition, for computer system validation role: knowledge and understanding of 21CFR Part 11/EU Annex 11, GAMP 5, and related industry standards required with familiarity with security regulations such as NIST SP and FISMA preferred.
- Quality Certifications Preferred (e.g., CQA, RAC, RQAP, ISO)
- Experience with Veeva Preferred
CONNECT WITH US
Follow us on Twitter - @EmmesCRO
Find us on LinkedIn - Emmes
#LI-Remote
-
501272 Clinical Scientist
2 semanas atrás
Mexico, Mexico City, Brasil IRE Tempo inteiro US$60.000 - US$120.000 por anoClinical Scientist - Home BasedICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Clinical Scientist to join our diverse and...
-
Associate Project Manager, Strategic
Há 7 dias
Mexico City, Mexico, Brasil IQVIA Tempo inteiro R$90.000 - R$120.000 por anoJob Overview:Project Management Analysts (PMA) are an integral part of clinical trial delivery, liaising with clinical teams to improve patients lives by bringing new drugs to the market faster. The PMA works in partnership with the Project Leader (PL)/Clinical Project Manager (CPM) providing support with project management activities to mitigate risk,...
-
Clinical Trial Manager
Há 5 dias
Mexico City, Mexico, Brasil IQVIA Tempo inteiro MX$60.000 - MX$120.000 por anoClinical Trial Manager – Sponsor Dedicated. Clinical Project Management services provide management of a clinical trial (s) in a regional level. Services/deliverables include operational oversight of assigned project(s) at the regional level for end-to-end project management from start-up through to closeout activities.Tasks & Responsibilities: •...
-
Assoc Mgr, Safety Operations
2 semanas atrás
Mexico City, Mexico, Brasil IQVIA Tempo inteiro MX$60.000 - MX$120.000 por anoJob OverviewThe Assoc Manager, Safety Operations Team is responsible for leading and overseeing all local pharmacovigilance activities, ensuring compliance with regulations and best practices. This includes the implementation, management, and maintenance of the local pharmacovigilance system.Key Responsibilities:Oversight of Pharmacovigilance...
-
Remote Quotation Lead Specialist
2 semanas atrás
Mexico |Colombia|Argentina |Venezuela|Honduras|Brazil|Brasil|Nicaragua|Guatemala|Costa Rica|Chile|Dominican Republic|Ecuador|El Salvador|Panama|Uruguay|Peru|Latin America|Belize HireLATAM Tempo inteiro US$17.400 - US$22.800 por anoHireLatam is a premier recruitment agency that places top Latin American talent in independent contractor roles in US companies. With a proven track record and a commitment to excellence, we're your trusted partner in the pursuit of career success. Our extensive network, personalized approach, and supportive guidance ensure that you're in the best hands to...
-
Regional Director, Data Security
Há 3 dias
City of London Corporation, GBR, Brasil Zscaler Tempo inteiro £80.000 - £120.000 por anoAbout ZscalerZscaler accelerates digital transformation so our customers can be more agile, efficient, resilient, and secure. Our cloud native Zero Trust Exchange platform protects thousands of customers from cyberattacks and data loss by securely connecting users, devices, and applications in any location.Here, impact in your role matters more than title...
-
City of London Corporation, GBR, Brasil Zscaler Tempo inteiro £60.000 - £100.000 por anoAbout ZscalerZscaler accelerates digital transformation so our customers can be more agile, efficient, resilient, and secure. Our cloud native Zero Trust Exchange platform protects thousands of customers from cyberattacks and data loss by securely connecting users, devices, and applications in any location.Here, impact in your role matters more than title...
-
Sales Operations Associate
2 semanas atrás
Brazil / Guatemala / Mexico / Panama / San Salvador, SV Hikinex Tempo inteiro CA$40.000 - CA$80.000 por anoOverviewOur client in Canada is looking for an energetic and experienced Sales Operations Associate to join our company. If you are enthusiastic and looking to join a vibrant team – this is a fantastic opportunity for you to delve into the sales realm.Job Summary:Working closely with the sales department in a support role assisting with various duties in...
-
Revenue Operations Lead
2 semanas atrás
São Paulo or Mexico City, Brasil Yalo Tempo inteiro R$80.000 - R$160.000 por anoYaloHi We're Yalo We're on a mission to revolutionize how businesses sell in an omnichannel way with our intelligent sales platform and intelligent agents powered by cutting-edge AI. Imagine a world where businesses seamlessly connect with their customers across every channel—offering personalized experiences, anticipating needs, and delivering what they...
-
Senior Data Engineer
2 semanas atrás
São Paulo / Greater Fortaleza / Rio de Janeiro / Florianópolis, Santa Catarina, Brazil / Buenos Aires Province / Bogota,D.C., Capital District / Mexico City Oowlish Technology Tempo inteiro R$60.000 - R$120.000 por anoJoin Our Team Oowlish, one of Latin America's rapidly expanding software development companies, is seeking experienced technology professionals to enhance our diverse and vibrant team. As a valued member of Oowlish, you will collaborate with premier clients from the United States and Europe, contributing to pioneering digital solutions. Our commitment to...
