QA Auditor - (R1038988) in Ithaca, NY at IQVIA™

Date Posted: 9/9/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Ithaca, NY
  • Experience:
    At least 3 year(s)
  • Date Posted:
    9/9/2018
  • Job ID:
    R1038988

Job Description

Launched in 2015, Q2 Solutions is a leading global clinical trials laboratory services organization. We help biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. Q2 Solutions is a quality driven, responsive partner with strong global experience and deep scientific and medical expertise. The Q2 Solutions joint venture was formed by Quintiles and Quest Diagnostics, combining the best of each parent organizations clinical trials laboratory services capabilities.

Description

PURPOSE
Plan, conduct, and report assigned quality assurance audits. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies. Provide quality assurance oversight under the direction of senior QA staff through interaction with customers, project and study teams and associated Quintiles functions.
 
RESPONSIBILITIES
  • Plan, schedule, conduct, report and close assigned audit activities in any of the countries involved with Quintiles contracts to assess compliance with applicable regulations/guidelines, customer requirements, Quintiles SOPs and project specific guidelines/instructions.
  • Conduct quality assurance activities and projects for clients according to Quintiles departmental or customer policies and procedures within budget and established timelines scheduling, conducting, reporting, and closing audits.
  • Assist in preparation and review of corrective action plans.
  • Represent quality assurance program on customer and project teams under the direction of more senior QA staff.
  • Document and report quality and compliance issues to QA management according to required timelines.
  • Advise quality assurance management on system audit needs.
  • Assist in hosting customer audits, mock regulatory inspections, and regulatory facility inspections by serving as Scribe, reviewing documents and identifying and calling operational staff to answer questions as needed. May host some customer audits independently as directed by QA line management.
  • Assist in preparation and review of corrective action plans associated with customer audits
  • Enhance and maintain a working knowledge of relevant GXP regulations
All responsibilities are essential job functions unless noted as nonessential (N).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
  • Knowledge of word-processing, spreadsheet, and database applications.
  • Considerable knowledge of GXP regulations and quality assurance auditing techniques.
  • Strong interpersonal skills.
  • Excellent problem solving skills.
  • Effective organization, communication, and team orientation skills.
  • Ability to initiate assigned tasks and to work independently.
  • Ability to manage multiple projects.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients

Job Requirements

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
  • Bachelor’s/primary degree
  • 3 years experience in pharmaceutical, technical, or related area including GXP and/or Quality Assurance experience; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience
PHYSICAL REQUIREMENTS
  • Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for
  • prolonged periods of time.
  • Position requires extensive use of telephone and face-to-face communications, which requires the accurate perception of
  • speech.
  • Travel is required and may include some international travel.
EEO Minorities/Females/Protected Veterans/Disabled

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.


Job ID: R1038988

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