Senior Quality Assurance Specialist (Auditor)
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:
- Compliance with ERT SOPs, Good Clinical Practices, and EN ISO 9001/ISO 13485 and applicable regulatory requirements. Includes all processes related to ERT’s System Development Life Cycle, Operations, and Quality Management System.
- Effectiveness of vendor Quality Management Systems, and their ability to meet ERT contractual agreements, ERT quality standards, and applicable regulations.
- Identification of potential/realized risks and determination of systemic approaches to effectively correct and prevent issues from recurring through utilization of risk based and control concepts.
- Data, processes and systems implemented by ERT are compliant with applicable regulations, guidelines, and internal procedures through quality reviews of primary study documentation and software applications.
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:
- Develops auditing plans and compiles reports for assigned audits at a level that requires minimal feedback from Quality Assurance Management.
- Reviews audit plans and reports developed by other QA Auditors and provides mentoring and feedback for development of their writing skills.
- Assigns and manages tasks to ensure that the audit is conducted efficiently and effectively.
- Oversees the mitigation and closure of observations by conducting proactive follow-up with the applicable departments to ensure timelines for corrective/preventive actions are met.
- Performs tracking/trending analysis of audit findings.
- Executes audits in compliance with the Annual Audit Schedule and completes reports within the timelines defined by ERT SOPs.
Acts in hosting role for management of client audits. Ability to demonstrate:
- Knowledge of ERT’s quality management system, regulatory requirements, business line products/services, and organizational structure.
- Acting as the liaison between ERT and the client, and coordinating with applicable department representatives when their participation is required.
- Effective distribution of audit requests and communications with auditors to address concerns.
- Successful client audit outcomes; Tracking/trending analysis of audit findings within the quality management tool.
- Analysis of observations identified; ability to oversee and work collaboratively with applicable departments to generate effective corrective and preventive action responses.
- Oversight of mitigation and closure of observations. Conduct follow-up with the applicable department to ensure timelines for corrective/preventive actions are met. Effectively communicates mitigation to clients.
Supports Continuous Improvement Program through:
- Effective investigation of issues and complaints including collaboration with applicable department head(s).
- Facilitation of root cause analysis to determine appropriate corrective and preventive actions.
- Management of Issues and Actions in quality management tool.
- Development of the Continuous Improvement Committee agenda.
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:
- Authors Quality Assurance/Regulatory Affairs standard operating procedures as required.
- Trains QA personnel on advanced concepts on auditing, quality management, or regulatory principles.
- Provides Annual Quality Assurance/Regulatory Affairs Training Courses to ERT staff, as necessary.
- Provides consulting services to contracted external sources as required.
- Assists in the development or execution of system testing as required. Participation in this task may only occur if the Quality Assurance Auditor is not assigned to the project in an audit role.
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:
- College Degree in Health/Life Sciences.
- 5-7years experience in a Quality Assurance capacity with a focus on GCPs and previous auditing experience. GMPs experience with medical devices is a plus.
- Knowledge of 21CFR Part 11, 21 CFR 820.20, ISO 9001/13485 and applicable regulatory authorities.
- Excellent leadership, analytical, organizational and communication skills.
- Detail oriented.
- Ability to write concise and accurate audit reports.
- Competent in Microsoft Office, especially spreadsheets, database and reporting tools. Experience with CAPA Management systems desired.
- Ability and willingness to travel at least 10-15% of the time (international and domestic).
- Ability to exercise good judgment, tact and confidentiality in all matters.