ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so we can adapt without compromising standards.
Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more than three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly — and with confidence.
Come help us make a difference in people's lives by joining our Boston office as a Senior Quality Assurance Specialist. The advanced quality audits and assessments of ERT’s procedures and data you will perform will assure compliance / quality of the services and systems developed and implemented by ERT to help innovate better health.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Performs internal/vendor audits, quality reviews and gap analyses of ERT’s operational and technical departments, processes and systems to ensure:
Manages multiple QA tasks in parallel and effectively prioritizes tasks to align with corporate quality objectives. Coordinates intra/interdisciplinary personnel through scheduled meeting and written communications, effective time management, tracking deliverables and when necessary, escalations to supervisor.
Acts in leadership role for joint department/vendor auditing efforts with other QA Auditors and oversees activities including:
Acts in hosting role for management of client audits. Ability to demonstrate:
Supports Continuous Improvement Program through:
Ability to oversee department initiatives effectively to support improved Quality Management functions such as document management, process development/management and QA tool administration.
OTHER DUTIES AND RESPONSIBILITIES:
The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. This job description and any attachments do not constitute or represent a contract.
QUALIFICATIONS AND SKILLS NEEDED:
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.