ERT is a global data and technology company that minimizes
uncertainty and risk in clinical trials so that our customers can
move ahead with confidence. With more than 45 years of clinical and
therapeutic experience, ERT balances knowledge of what works with a
vision for what's next, so it can adapt without compromising
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. Over the past
four years, more than half of all FDA drug approvals came from
ERT-supported studies. Pharma companies, Biotechs, and CROs have
relied on ERT solutions in 9,500+ studies spanning 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. For more information, go to
ert.com or follow us on LinkedIn, Twitter, and Facebook.
Come help us make a difference in people's lives by joining our
office as a Quality Assurance Auditor. 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
- 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
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
Acts in leadership role for joint department/vendor auditing
efforts with other QA Auditors and oversees activities
- Develops auditing plans and compiles reports for assigned
audits at a level that requires minimal feedback from Quality
- Reviews audit plans and reports developed by other QA Auditors
and provides mentoring and feedback for development of their
- 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
Acts in hosting role for management of client audits. Ability to
- Knowledge of ERT's quality management system, regulatory
requirements, business line products/services, and organizational
- 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
- Development of the Continuous Improvement Committee
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
- 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
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
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.
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