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Company

IQVIA · 5 hours ago

Quality Assurance Auditor 1

Durham, NC

Full-time

Remote

Entry Level

$52K/yr - $86K/yr

1+ years exp

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AnalyticsHealth Care

H1B Sponsor Likely

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Responsibilities

Assisting in conducting quality assurance audits within budget and established timelines by scheduling, conducting, reporting, and closing audits as directed by the lead auditor.

Contacting auditees to agree on audit dates and make appropriate entries in the QA database.

Performing data reviews and filing audits as directed.

Entering and categorizing audit/inspection findings in eQMS.

Soliciting follow-up information and closing audits/inspection findings in the QA database.

Reviewing and approving Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plans.

Supporting investigators with derogatory status management in the database, preparing and releasing guidance documents with compliance information, and maintaining the QA repository with compliance information for investigators with derogatory status.

Assisting in hosting customer audits, mock regulatory inspections, and regulatory facility inspections by acting as a scribe, reviewing documents, identifying and calling operational staff to answer related questions, and performing required administrative duties.

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.

Quality AssuranceGXP regulationsAudit techniquesWord-processing applicationsSpreadsheet applicationsDatabase applicationsTeam orientation skills

Required

Bachelor’s Degree in a relevant field.

1 year of Quality Assurance experience in pharmaceutical, technical, or related area, including GXP and/or Quality Assurance experience.

Other equivalent combination of education, training, and experience may be accepted in lieu of degree.

Knowledge of word-processing, spreadsheet, and database applications.

Considerable knowledge of GXP regulations and quality assurance auditing techniques.

Strong interpersonal and problem-solving skills.

Effective organization, communication, and team orientation skills.

Company

IQVIA

Glassdoor

3.9

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

Founded in 1982

Danbury, Connecticut, USA

10,001+ 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)