QA Auditor 1 (Future Opportunities in Ithaca, NY) (R1119847) in Ithaca, NY at IQVIA™

Date Posted: 3/20/2020

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Ithaca, NY
  • Experience:
    Not Specified
  • Date Posted:
    3/20/2020
  • Job ID:
    R1119847

Job Description

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

JOB SUMMARY

Assist lead auditors/audit liaisons in conducting, hosting and reporting quality assurance audits by performing specific audit tasks under the direct supervision of more senior QA staff.

RESPONSIBILITIES

  • Assist in conducting quality assurance audits within budget and established timelines by scheduling, conducting, reporting, and closing audits as directed by the lead auditor. Activities may include contacting auditees to agree on audit dates, making appropriate entries in QA database (audit demographics, dates, and personnel,), performing data reviews, file audits, etc. as directed, entering and categorizing audit findings in the QA audit tracking database, soliciting follow-up information and closing audits/findings in the QA database.
  • Assist in review of corrective action plans for completeness and accuracy
  • Document and report quality and compliance issues to QA line management within specified regional timelines.
  • Assist in hosting customer audits, mock regulatory inspections, and regulatory facility inspections by acting as a scribe, review documents, and identifying and calling operational staff to answer related questions and performing required administrative duties including tracking of documents reviewed, scheduling audit team members for interviews and coping and stamping documents for release to the auditors/inspectors.
  • Obtain a fundamental knowledge of current relevant GXP regulations, guidelines, and related auditing techniques.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor's Degree  plus 1 year Quality Assurance experience in pharmaceutical, technical, or related area, including  GXP and/or Quality Assurance experience OR Equivalent combination of education, training and experience

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1119847

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