Job Information
PAREXEL International LLC Audit Specialist in United States
My research opens up new medical possibilities.
And I Do It
Search Jobs
Search Jobs
Keyword:
Location:
Radius:Enter distance515253550
UnitMILESKM
Search Jobs
View Remote JobsView All Jobs
Audit Specialist Durham, North Carolina, United States of America Job IDR0000021413 CategoryQuality Management
Apply Now (https://wd1.myworkdaysite.com/recruiting/parexel/Parexel_External_Careers/job/United-States---Durham---North-Carolina/Audit-Specialist_R0000021413) Save Job
About this Role
Durham, NC (Hybrid Role)
The Sr Audit Specialist will have the experience and knowledge to provide guidance and facilitate the effective preparation, management and follow up of Sponsor Audits and Regulatory Inspections. Will exhibit a high degree of flexibility and initiative, demonstrate the ability to follow up on multiple tasks and
projects, and possess the ability to handle confidential information.
End-to-End Facilitation of Sponsor Audits
Liaise with the Sponsor and Parexel project team, Quality Assurance Management and staff, throughout the lifecycle of an Audit
Conduct all preparation meetings, assign tasks with other internal departments and gather necessary information on Sponsor confidentiality agreement documentation.
Initiate planning process(es), e.g., project plans with deadlines and milestones, to administer an audit effectively and seamlessly
-Ensure audits are performed to a high degree of client satisfaction
-Build, develop, and maintain good working relationships with internal and external customer groups
Determine most appropriate setting to host an audit, based upon sponsor audit requirements
Actively support audit host throughout a sponsor audit onsite (where applicable)
Support Non-Parexel-facility audits, e.g. supplier sites, internal audits at sponsor offices, as applicable
Ensure that Technical Enterprise Tools e.g., extranet, PMED, PMEX and Microsoft Teams are set up correctly, are tested and tailored to the Sponsors specific requirements
Support the maintenance of SAIG Tools
Summarize quality issues arising from sponsor audits and other related activities, as requested.
Enter Sponsor audit information into the Parexel audit module of eQMS and provide follow up on outcomes, as needed.
With First Time Quality – ensure that information is added and relayed effectively and correctly
Development / Review of Procedures
Create or contribute to Lessons Learned after any audit activity hosted, to ensure continuous quality improvement
Proactively recognize areas for process / procedural improvements, providing input to management and taking the initiative, as appropriate.
Ability to review and offer feedback of associated standard operating procedures, from a QA perspective.
Maintain GXP and Regulatory Awareness
Maintain relevant knowledge of appropriate GxP requirements and developments as they impact Parexel’s international SOPs and compliance with GxP. Communicate to QA team and management, as applicable
Promote compliance within the company and represent QA, as required
Proactively re/review QA SOPs and be able to speak to their contents
Develop and maintain network contacts with other Quality Assurance professionals
Support regulatory inspections as needed
Build and Maintain Relationships
Build, develop, and maintain good working relationships with internal and external customer groups.
Work well in team environment.
Travel on assignments as required.
- Travel time could be up to 20%.
Education
- Educated to the degree level (BS, BA) or equivalent experience
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.