ERT

Quality Assurance Auditor

Job Location US-PA-Philadelphia | US-OH-Cleveland | US-PA-Pittsburgh
Shift
Full Time Regular
Type
Regular Full-Time

Overview

ResearchTechnology (ERT) provides unparalleled service and reliable solutions with a common purpose - to ease the challenges of product safety and testing efforts while improving and saving lives. Our important work sets the industry standard. Our team provides proven scientific and regulatory leadership to biopharmaceutical and medical device companies around the world. Our global clients rely upon our expertise - across Cardiac Safety, Respiratory research, ePRO, and Consulting Solutions - to expedite their clinical research studies and empower them to make their expert decisions, more quickly and accurately, related to their product development and approval efforts.

 Our global company is growing. Our aim is to lead clinical studies to success and to make a contribution to public health.  We identify and reward great talent. We're refreshingly friendly and our teamwork is unrivaled.

 

ERT is looking to hire a QA Auditor to perform quality audits and assessments of ERT’s procedures
and data to assure compliance and quality of the services and 
systems developed and implemented by ERT.

Responsibilities

The Role of Quality Assurance Auditor is repsonsible for the following;

 

Perform internal audits and gap analyses of ERT’s operational and technical departments and processes to ensure compliance with ERT SOPs, Good Clinical Practices, and EN ISO 9001/ISO 13485 and applicable regulatory requirements. This includes all processes related to ERT’s System Development Life Cycle.

 

Perform audits of ERT’s vendors to assess their Quality Management System, and their ability to meet ERT contractual agreements, ERT quality standards, and applicable regulations.

 

Assist with the hosting and management of client audits. Analyze any observations identified and work with applicable departments to generate effective corrective and preventive action responses.


Develop auditing plans and compile reports for assigned audits.

 

Manage corrective action and preventive action responses received for internal and vendor audits, and responses defined for external audit observations. Conduct follow-up with the applicable departments to ensure timelines for corrective actions are met.


Perform tracking/trending analysis of audit findings.

 

Perform quality reviews of key documents defined by ERT’s System Development Life Cycle
specifically related to:
   Medical Device Development/Change Control

   System Requirements
   Testing/Validation Records
   Installation Qualification
   System Maintenance Records
   Migration Records

Qualifications

Candidates who offer the following qualifications, skills, knowledge and experience are encouraged to apply indicating ndicate your salary expectations and availability via our ERT career page.

 

College (4-year) degree in Health/Life Sciences.

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 computer skills.

 

Ability and willingness to travel at least 10-15% of the time (international and domestic).

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