Quality Assurance Auditor 2

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.

Purpose

Ensures the organization's operations are consistent with Good Clinical Practices (GCPs) required for submission of data to regulators that support filing of data to support market authorization of new healthcare therapies.

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 contracts to assess compliance with applicable regulations/guidelines, customer requirements, SOPs and project specific guidelines/instructions.

• Conduct quality assurance activities and projects for clients according to 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

Required Knowledge, Skills and Abilities

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

• Considerable knowledge of GxP regulations and quality assurance auditing techniques.
• Knowledge of GLP very helpful.

• 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 co-workers, managers and clients.

Minimum Required Education and Experience

Bachelor’s degree and 3 years’ experience in pharmaceutical, technical, or related area including GLP, GXP and/or Quality Assurance experience

Equivalent combination of education, training and experience.

What We Offer

• Major Medical, Vision, Dental, Disability
• Annual bonus
• 401(k) with 100% with immediate vesting
• Tuition Reimbursement up to $6k annually
• Generous paid time off and holiday leave
• Other generous benefits

EEO Minorities/Females/Protected Veterans/Disabled

Keywords:  Audit, SOP, GxP, GCP, GLP

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.