Emmes · 3 months ago
Senior Quality Assurance Specialist
United States
Full-time
Remote
Mid, Senior Level
4+ years expEmmes Group is a leading clinical research provider focused on transforming the future of medical discovery. They are seeking a Senior Quality Assurance Specialist to lead audits, review documentation, and mentor team members while ensuring compliance and quality in clinical research processes.
BiopharmaBiotechnologyClinical TrialsHealth CareMedical
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
Qualification
Required
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)
Preferred
Quality Certifications Preferred (e.g., CQA, RAC, RQAP, ISO)
Experience with Veeva Preferred
Company
Emmes
Emmes is a contract research organization that offers clinical research services for public health and biopharmaceutical innovation.
1001-5000 employees
H1B Sponsorship
Emmes has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (6)
2023 (6)
2022 (11)
2021 (6)
2020 (4)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Behrman Capital
2022-06-21Acquired
2019-03-04Private Equity
Leadership Team
Peter Ronco
Chief Executive Officer
Recent News
2025-09-20
2025-01-18
2024-12-10
Company data provided by crunchbase