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Senior Quality Analyst, IT

Parexel International Corporation

Durham, North Carolina

Parexel is hiring a Senior Quality Analyst to support development and provide continuous improvement of key components of the Quality and Compliance within Corporate IT.

Activities may include:Coordinate monthly IT Quality metrics reviews, including CAPA and Audit Finding assignments and progress Support the identification, management and prevention of risks and quality issues.Provide audit and inspection support and coordinate data for monthly IT Quality metrics reviews, including CAPA and Audit Finding assignments and progress. Facilitate cross functional working meetings between IT and Quality approvers to address quality issuesIdentification of gaps and/or improvement opportunities; process authoring and review; support for process re-engineering; contribution to the development of training materials as IT Quality subject matter expert.Provide Good Practices (GxP) and QMS expertise to Parexel Corporate IT group(s).Manages status and progress of multiple CAPAs and audit findings simultaneously, and aggressively facilitates each assigned issue to a timely closure Coaches and mentors other employees on CAPA execution and methodology.Active participation in External Audits, Management Reviews, and Internal Audits as requested.Other duties may be assigned by manager.QualificationsSkills: Excellent interpersonal, verbal and written communication skillsCustomer focused approach to workA flexible attitude with respect to work assignments and new learningAbility to manage and prioritize tasks efficiently and accuratelyWillingness to work in a matrix environment and to value the importance of teamworkUnderstanding of audit/inspection processAbility to lead projects and teamsStrong ability to analyze and interpret dataAttention to detail and advanced organizational skillsAbility to work independently and take ownership of and responsibility for work assignedIT literate – Experience with Microsoft based applications and a general knowledge of PC functionsCulturally aware and ability to think and work globallyEnglish proficiency (written and oral English)Knowledge and Experience: Relevant experience in the IT regulated environments such as Clinical Research, Pharmaceutical, Medical Device industries or other relevant experience in the areas of QMS support requiredKnowledge of GxP compliance requiredProject Management / Technology / Business Operations experience, as appropriate, preferredExperience working in a global environmentRelevant experience in Quality Management preferredEEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job posted: 2021-09-09

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