31 applicants

Company

IQVIA · 12 hours ago

CFSP Quality Specialist; CAPA Management

Raleigh, NC

Full-time

Remote

Mid Level

$76K/yr - $126K/yr

3+ years exp

Maximize your interview chances

AnalyticsHealth Care

H1B Sponsor Likely

Insider Connection @IQVIA

Discover valuable connections within the company who might provide insights and potential referrals.
Get 3x more responses when you reach out via email instead of LinkedIn.

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

Glassdoor

3.9

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

Founded in 1982

Danbury, Connecticut, USA

10001+ employees

https://www.iqvia.com

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)