Lab Quality Specialist

Job Overview
The Lab Quality Specialist is responsible for supporting lab quality control processes and improvements.

Essential Functions
• Responsible for providing Quality Control (QC) documentation support to operations.
• Performs QC review of lab documentation to ensure accuracy and compliance with applicable regulations and SOPs.
• Supports the review and update of QC related SOP's.
• Supports client audits by responding to routine inquiries and review of documentation ahead of audit to ensure readiness. Flags identified gaps to senior level staff.
• Supports quality control educational programs: in-house workshops, presentations, training and seminars for new hires and existing staff. Assists in drafting materials and lab staff training delivery.
• May work with management to update job training matrix.
• Coordinates and schedules all assigned quality control projects with minor assistance from coworkers and manager.
• May track and report deviation QC trends to management.
• Participates in QC and company staff meetings and discuss findings and recommendations for resolving non-compliance.
• Evaluates QC processes for gaps, recommend actions and communicate to management the analysis to support the continuous improvement of lab quality.
• Mentors and guides junior level staff. Supports the onboarding of new hires.
• Participates in continuing education through self-study, attending training sessions and  lectures and meetings.
• Supports safety, quality, and 6S requirements and initiatives.
• Complies with company's procedures and regulatory requirements, as applicable.

Qualifications
• Bachelor's Degree in medical technology or equivalent Req
• 1 year experience in a regulated laboratory environment.
• Requires sound knowledge of laboratory quality systems and laboratory procedures.
• Requires sound knowledge of laboratory good documentation practices.
• Demonstrated ability to identify lab quality process gaps and propose basic resolution.
• Good computer skills using Microsoft Outlook, Word and Excel.
• Effective organizational and interpersonal skills.
• Effective communication and presentation skills.
• Capable of handling multiple tasks simultaneously.
• Strong attention to detail and accuracy.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
•  Applicable certifications and licenses as required by local regulations.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.