CFSP Quality Specialist; CAPA Management @ IQVIA | Jobright.ai
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CFSP Quality Specialist; CAPA Management jobs in Raleigh, NC
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IQVIA · 7 hours ago

CFSP Quality Specialist; CAPA Management

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Responsibilities

Act as process and system SME for the nonconformance and CAPA process and business/system requirements
Assist the Investigation Owner (10) in the application of structured problem-solving methodologies in Root Cause Analysis (RCA) investigations (Fishbone, 5 Whys, etc) independently or in support of the Root Cause Investigation team
Coach the Investigation Owner in understanding their end-to-end accountability of the entire CAPA process
Develop and maintain proficiency in the TrackWise ETS QEM system
Work with the organization to identify resources to support RCA investigations and resulting actions
Provide assistance to the record owner to ensure process requirements are met
Monitor nonconformance and CAPA deliverables / timelines for functional area by running reports, communicating upcoming deadlines to record owners and escalating concerns to management as appropriate to actively drive compliance
Act as a liaison between the record owner and the quality leader; the record owner and the Root Cause Analysis group; the record owner and the TrackWise central entry team.
Escalate any issues, as needed, to the BRQC Janssen CAPA Review Board Raise any process or system questions or concerns to the CAPA Champions Community of Practice
Manage requests for assistance from the TrackWise central data entry team on behalf of the 10

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

CAPA processRoot Cause AnalysisTrackWise ETS QEMQuality AssuranceGXP experiencePharmaceutical IndustryClinical researchSOPsData analysisProcess improvementBusiness processes

Required

Bachelor’s Degree or experience in lieu of a degree.
Pharmaceutical Industry experience is required, with at least 3-4 years of GXP experience within clinical research and development and/or quality assurance.
Experience in Quality Control and Compliance, Quality Assurance, CAPA process and/or Root Cause Analysis.
Knowledge of the overall drug development process
Well-developed skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities)
Ability to translate data into information and strategies into executable action plans improving the business
Ability to motivate professional colleagues and stakeholders
Conflict resolution/management and negotiation skills
Ability to independently plan, organize, coordinate, manage and execute assigned tasks
Experience of the key customers' business processes and practices

Preferred

Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset

Benefits

Health and welfare and/or other benefits

Company

IQVIA provides analytics, compliance, and management solutions to the life sciences industry.

H1B Sponsorship

IQVIA has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (218)
2022 (199)
2021 (286)
2020 (197)

Funding

Current Stage
Public Company
Total Funding
$1.5B
2023-11-14Post Ipo Debt· $500M
2023-05-18Post Ipo Debt· $1B
2019-08-08Post Ipo Equity

Leadership Team

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Chris Colapietro
Vice President, Customer Engagement
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Christina Bodurow
Vice President, Global Regulatory Affairs
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Company data provided by crunchbase
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