Senior Quality Assurance Auditor Job in Warsaw 00-807, Mazowieckie Poland

INC Research is looking for an experienced QA professional in Poland for a Senior Quality Assurance (QA) Auditor position to extend the global QA team. This is an office based position.

The Senior Quality Assurance (QA) Auditor conducts audits of on-going clinical research and data management projects, as well as assists with handling other QA program initiatives.

 

Essential Job Functions

 

1.      Conducts and documents assigned audits of the projects and operational processes in accordance with approved procedures, schedules and formats.  Specific audit areas will include but not be limited to:

 

×          Investigator Sites

×          Trial Master and Project Management Files

×          Project Databases (and their development)

×          Data Management Activities and documentation

×          Safety Reporting

×          Final/Clinical  Study Reports

×          Staff Training Records

×          Vendors

 

2.      Writes and issues audit reports in accordance with standard Company formats and timelines, ensuring clear communication of audit findings to the relevant project team members and/or functional area management.  Reviews responses to audit findings for appropriateness and completeness.

 

3.      Maintains documentation and status of QA auditing activities as outlined by applicable SOPs and WIs.

 

4.      Serves as a mentor to less experienced QA Auditors.

 

5.      Serves as Lead Auditor on team-based audits and/or for project audits.

 

6.      Manages assigned quality issues in accordance with Company requirements.

 

7.      Hosts sponsor audits as assigned.

 

Performs other work-related duties as assigned.  Extensive travel may be required (at least 50%), domestically and internationally.

Requires a Bachelor’s degree in a science/health care field with significant experience in clinical quality assurance auditing, including investigator site audits, audits of data management activities and vendor audits.  Requires strong and comprehensive knowledge of applicable Good Clinical Practice regulations and Guidelines as well as medical terminology.  Ability to handle multiple tasks to meet deadlines in a dynamic environment is a must.  Strong organizational, presentation, documentation and interpersonal skills with diverse cultures needed.  Ability to negotiate and provide constructive feedback is essential.  Must be able to work as part of a team as well as independently.  Well-developed communication skills and the ability to write and present concise, accurate reports and other necessary documentation. Proficient use of computer and Microsoft software programs and Email and voice mail communication systems is a must.  Ability to work nights and week-ends as needed.