Job Description

Quality Assurance Auditor



Primary Location: Valencia, California, United States Full time R1165441 Date Posted: 01/11/2021

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 organizations clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

Job Overview
Conduct and/or support audits and report preparation/distribution, Support quality issues management, Customer Audit/ Regulatory Inspections hosting, Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plan review, approval and closure and Audit plan development. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies, lead/support in QA initiatives/projects for quality, process improvements

Essential Functions
Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, Standard Operating Procedures ( SOPs) and project specific guidelines/instructions.
Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
Provide consultation to customers and monitors in interpretation of audit observations
Host audits/inspections,Ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections. May perform GLP Archivist duties where needed.
Manage Quality Issues
Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans. Track until closures for quality events arising from Quality Issues, Audits, Inspections or during similar QA activities
Present educational programs and provide guidance to operational staff on compliance procedures.
Provide quality assurance consultancy activities and projects for clients within budget and established timelines.
Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
Assist in training of new Quality Assurance staff.
Support in QA initiatives/projects for quality, process improvements
Manage/oversee quality events updates in eQMS
Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle

Qualifications
Bachelor's Degree Req
3 years experience in pharmaceutical, technical, or related area including GXP and/or Quality Assurance experience. Equivalent combination of education, training and experience.
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..

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 IQVIAs Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.