Senior Quality Assurance Specialist
full-time•São Paulo, Panama City, São Paulo
About this role
Overview
Responsibilities
Qualifications
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
- Leads audits of internal processes, suppliers, and investigator sites
- Reviews documentation for accuracy and compliance (e.g., CAPAs, quality incidents, audit reports, etc.).
- Reviews, facilitates, and tracks quality incidents, deviations, and CAPAs.
- Hosts client audits and regulatory inspections.
- Leads or participates in process improvement projects.
- Writes and reviews Quality SOPs and Policies.
- Conducts trainings on quality topics, as assigned.
- As a subject matter expert, provides guidance and 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.
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.
Qualifications
- Bachelor’s degree in Life Sciences or a related scientific field and 4- 6 years related experience.
- Experience working in a ICH GCP regulated environment
- Knowledge and understanding of GCP regulatory requirements and implementation (FDA, EU, ICH and country specific regulations and relevant guidance)
- Quality Certifications Preferred (e.g., CQA, RAC, RQAP, ISO)
- Experience with Veeva Preferred
CONNECT WITH US!
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Find us on LinkedIn - Emmes
#LI-Remote
What you'll do
- The Senior Quality Assurance Specialist leads audits of internal processes, suppliers, and investigator sites while reviewing documentation for accuracy and compliance. They also host client audits, participate in process improvement projects, and provide guidance to less experienced team members.
About Emmes Global
For over 40 years, our team of 1,000+ experienced professionals have provided the full range of Contract Research Organization expertise necessary to conduct clinical research with a firm scientific basis that is fully compliant with national and international regulatory guidelines. With offices throughout the US, Europe, Canada, and India, Emmes supports the advancement of global public health and biopharmaceutical innovation through disciplined science, rigorous research, fact-based decision-making, and operational excellence.
Emmes possesses knowledge across a broad range of therapeutic areas, with specializations in Vaccines and Infectious Diseases, Ophthalmology, Immunology and Neuroscience. From comprehensive support of pandemic research to groundbreaking work in cell and gene therapy across the globe, Emmes has collaborated on clinical research across a wide array of disease states in over 75 nations.
As a strategic collaborator with applied talent in over 2,000 clinical trials and contributions to over 2,500 publications that advance the understanding of medicine and public health, Emmes is committed to expanding the services offered to best meet the changing needs of clients and studies. Ongoing investments in global clinical research capabilities, innovative data management platforms, biostatistics/bioinformatics expertise, and people have enabled Emmes to provide a multi-faceted approach to help you meet your research objectives.
Emmes is a diverse, inclusive, innovative CRO that values integrity, agility, passion for excellence, collaborative partnerships, and intellectual curiosity.
Ready to join Emmes Global?
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Frequently Asked Questions
What does a Senior Quality Assurance Specialist do at Emmes Global?
As a Senior Quality Assurance Specialist at Emmes Global, you will: the Senior Quality Assurance Specialist leads audits of internal processes, suppliers, and investigator sites while reviewing documentation for accuracy and compliance. They also host client audits, participate in process improvement projects, and provide guidance to less experienced team members..
Is the Senior Quality Assurance Specialist position at Emmes Global remote?
The Senior Quality Assurance Specialist position at Emmes Global is based in São Paulo, Brazil and Panama City, Panamá Province, Panama. Contact the company through Clera for specific work arrangement details.
How do I apply for the Senior Quality Assurance Specialist position at Emmes Global?
You can apply for the Senior Quality Assurance Specialist position at Emmes Globaldirectly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process.