Sr Quality Analyst
Advarra
Summary
The Sr Quality Analyst will play a key role in ensuring that Advarra's products and services meet the highest standards of quality, compliance and expectations of its customers and stakeholders. This role involves conducting various assessments, reviews and audits on our products and services, identifying and resolving any issues that may affect the quality, compliance or customer satisfaction, such as errors, risks or non-conformities, and providing feedback and recommendations for improvement. The Sr Quality Analyst collaborates with other teams and stakeholders across the company to define and implement quality standards, processes and best practices.
Job description
Job Duties & Responsibilities
- Conduct internal audits and host audits in compliance with FDA and other applicable regulations to ensure adherence to regulatory and client requirements.
- Manage client assessments to help clients qualify Advarra for new and on-going business and do so in a timely manner while trying to convey details accurately.
- Develop and implement Corrective and Preventive Action reports (CAPAs) to address any issues identified during audits or assessments to enhance company quality performance, reduce risks, increase customer satisfaction, and comply with regulatory requirements.
- Develop and maintain Standard Operating Procedures (SOPs) to ensure that company processes are consistent and effective, help avoid errors, reduce variability, improve quality, and comply with regulations and best practices.
- Support management of suppliers to ensure that they meet Advarra's expectations; conduct audits and assessments to evaluate supplier performance and compliance with Advarra's standards and requirements.
- Maintain an appropriate level of independence; to ensure that work performed is objective, unbiased, and credible, and constructive feedback and recommendations are provided to improve the quality outcomes.
- Other duties as assigned.
Basic Qualifications
- Bachelor's degree or equivalent work experience.
- 5+ years' in clinical research, healthcare or GxP environment.
- Ability to work independently; effectively balances team and individual responsibilities.
- Ability to utilize software such as Word, Excel, Access, PowerPoint, SharePoint; ability to learn new software as required and remain proficient in all programs necessary to perform duties of this position.
- Effectively and professionally communicate with all levels of staff and clients.
Preferred Qualifications
- GCP experience preferred.
- Working knowledge of Federal regulations for human research and data protection (21 CFR 50, 56, 312, and 812; and 45 CFR 46, 21 CFR Part 11).
- Contributes to building a positive team environment through collaboration.
- Demonstrates accuracy and thoroughness.
- Excellent organizational skills, managing conflicting demands and priorities, without compromising quality.
- Ability to exercise sound judgement and initiative.
- Ability to identify and resolve problems in a timely manner.
Requirements
- Bachelor's degree or equivalent work experience
- 5+ years' in clinical research, healthcare or GxP environment
- Ability to work independently; effectively balances team and individual responsibilities
- Ability to utilize software such as Word, Excel, Access, PowerPoint, SharePoint
- Effectively and professionally communicate with all levels of staff and clients
- GCP experience preferred
- Working knowledge of Federal regulations for human research and data protection (21 CFR 50, 56, 312, and 812; and 45 CFR 46, 21 CFR Part 11)
- Excellent organizational skills, managing conflicting demands and priorities
- Ability to exercise sound judgement and initiative
- Ability to identify and resolve problems in a timely manner
Benefits
- Health coverage
- Paid holidays
- Variable bonus
Company overview
Advarra is a leading provider of clinical research technology and regulatory review services, serving as a comprehensive partner to the entire research ecosystem. Founded in 1983 and headquartered in Columbia, Maryland, the company operates globally with offices across North America, Europe, and Asia. Advarra combines over 40 years of Institutional Review Board (IRB) leadership with advanced technology solutions to streamline clinical trial operations. The company's core services include ethical review services (IRB and IBC), data monitoring, endpoint adjudication, consulting services, and clinical trial management systems. Advarra's innovative Braid platform leverages artificial intelligence and data analytics to provide operational intelligence and automation throughout the protocol lifecycle. With approximately 1,800 employees worldwide, the company supports over 50,000 investigators and study teams, helping sponsors, CROs, and research sites conduct clinical trials more efficiently, ethically, and transparently. Advarra's integrated solutions reduce administrative burden while ensuring regulatory compliance and participant safety across the clinical research continuum.