QC Inspector 1

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 Profile Summary

The QC Inspector 1 applies quality control experience and extensive knowledge of process review into practical quality solutions for the organization.  The QC Inspector 1 evaluates, monitors, and systematically recommends corrective actions of procedures and processes.  Professionally conducts reviews with a high level of communication that yields quality results.

Responsibilities

 Essential Functions

• Provide Quality Control (QC) support to operations.
• Perform QC review of Sample Login binders, Bioanalytical run binders, Wet Lab notebooks, data tables, data table summaries and electronic submissions.
• Participate in review and development of technical and QC SOPs to ensure compliance with appropriate regulations.
• Actively participate in QC educational programs: in-house workshops, presentations on current QC issues, QC training and QC Seminars for all new employees, etc.
• Lead or assist director in leading QC and staff meetings and discuss findings and recommendations for resolving non-compliance.
• Work closely with operation individuals to improve quality systems.
• Manage and schedule all assigned quality control projects with minor assistance from coworkers and manager.
• Communicates progress and strategic planning to the Director of Quality Assurance, or designee, in clear and concise appraisal with recommendations.
• Track and report deviation trends to management.
• Utilize root cause analysis to evaluate all systems for gaps, recommend action and professionally communicate to management the analysis to continually improve quality.
• Design, develop and implement new QC procedures.
• Demonstrate continuous self-motivated quality development.
• Proactively take steps to improve quality systems.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelor's Degree and 3 years’ relevant experience in a quality / laboratory environment, including  GXP and/or Quality Assurance experience or equivalent combination of education, training and experience.                  

Skills and Abilities

• Laboratory experience in a GXP environment.                   
• Knowledge of word-processing, spreadsheet, and database applications.               
• Knowledge of GXP regulations and guidelines and basic 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 IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.