Overview: Senior Quality Assurance SpecialistLATAM RemoteEmmes 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 PurposeThe 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 general 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 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 800-53 and FISMA preferred.- Quality Certifications Preferred (e.g., CQA, RAC, RQAP, ISO)- Experience with Veeva PreferredCONNECT WITH US!Follow us on Twitter - @EmmesCROFind us on LinkedIn - Emmes#LI-Remote
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