Lab Quality Control Inspector – IQVIA – Durham, NC

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.

Responsibilities

• Provide Quality Control (QC) documentation support to operations.
• Perform QC review of documentation such as Sample Login binders, run binders, extraction paperwork, Lab notebooks, Data tables, and reports Participate in review 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.
• Participate in QC and company staff meetings and discuss findings and recommendations for resolving non-compliance.
• Work in conjunction with operation individuals to improve quality systems.
• Manage and schedule all assigned quality control projects with minor assistance from coworkers and manager.
• May track and report deviation trends to management.
• Evaluate all systems for gaps, recommend actions and professionally communicate to management the analysis to continually improve quality.
• Demonstrate continuous self-motivated quality development.
• Proactively take steps to improve quality systems.

Minimum required education and experience

• Bachelor’s Degree required
• Equivalent combination of education, training and experience may be substituted for degree

Required knowledge, skills and abilities

• Laboratory experience in a GLP environment.
• Knowledge of word-processing, spreadsheet, and database applications.
• Knowledge of GLP regulations and guidelines and basic quality review 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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

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 [email protected] to arrange for such an accommodation.