Lab Quality Specialist

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

Establish and monitor laboratory quality and technical systems including assay quality control, proficiency testing review, the scientific database and global laboratory meetings. Collaborate with the assay development laboratory, regional production laboratories, scientific review, data management, vendors and laboratory management as necessary in the execution and fulfilment of duties.

RESPONSIBILITIES

• Perform global assay quality control reviews, monitor regional and/or global trends, implement corrective actions when needed to establish or restore acceptable global performance
• Evaluate regional laboratory investigations performed for proficiency testingfailures looking at global impact and trends
• Supervise the input of data into the Scientific Database and the test code system
• Manage inter-lab and vendor orders/shipments to maintain global inventory stock levels for harmonized reagents, calibrators and quality control material.
• Interact with vendors/assay manufacturers regarding technical assay information required to maintain quality assay performance
• Provide training to Global Harmonization team and regional laboratory teams, as needed
• Minute and/or facilitate global technical meetings

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Knowledge of clinical and/or research laboratory environment and safety and infection control procedures.
• Knowledge of laboratory equipment, clinical laboratory assays, quality control and validation procedures.
• Advanced Excel spreadsheet skills
• Ability to balance multiple priorities
• Ability to establish and maintain effective working relationships with co-workers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Bachelor’s degree in medical technology or equivalent experience within a research

laboratory/clinical laboratory environment required or an equivalent combination of training, education and experience.

PHYSICAL REQUIREMENTS

• Extensive use of keyboard requiring repetitive motion of fingers.
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• Regular sitting for extended periods of time.