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.
Mentor new hires within the department. Responsible for the completion of competency forms and associated documentation
related to their training activities.
Lead and develop the execution of local laboratory technical support, communicates with and provides guidance and relevant
test data to stakeholders.
Oversee the local laboratory Technical Support Helpdesk staff with inquiries from other departments and clients requesting
specific laboratory information.
Develop and lead the local clinical laboratory quality program including statistical analysis, by providing guidance to laboratory
staff and communicating with laboratory management, global quality control and global lab harmonization groups as required.
Develop and lead in validating (new) assays through statistical analysis and troubleshooting of local laboratory data, and acts
as a technical specialist for stakeholders in the effective implementation of analytical methods in the local lab.
Develop, lead and act as contact person on all aspects and phases of proficiency testing and accreditation programs within
the local lab.
Develop and lead the yearly schedules for the local laboratory for regulatory functions and completes data analysis by
performing linearity and comparison studies, or other studies as required by various agencies and/or as requested by
Responsible for all system lifecycle activities and associated deliverables pertaining to local laboratory instruments and
equipment, including the design, testing, and execution of qualification activities, calibration, maintenance, change control and
retirement activities, to ensure effective implementation and maintenance of local laboratory instruments and equipment to the
Initiate, lead and communicate on a technical level with manufacturers, global organizational colleagues and/or System
Compliance Office related to their daily activities on both a regional or global basis.
Work with Global Lab Harmonization to initiate the drafting of new standard operating procedures (SOPs) and the
maintenance of existing SOPs related to the departmental activities on both a regional or global basis.
Represent Technical Services team in audits/inspections from regulatory agencies and pharmaceutical sponsors of the local
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Typically requires 2 - 3 years of prior relevant experience.
Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced
education combined with experience.
Bachelor's Degree in life sciences or other relevant field
3 years relevant clinical laboratory experience Or Equivalent combination of education, training and experience
Skills and Abilities
Knowledge of clinical laboratory regulations, GxP and/or ICH guidelines
Knowledge of laboratory equipment, clinical laboratory assays, quality control and validation procedures
Proficiency in PC applications such as word processing, spreadsheets, database management
Excellent attention to detail, organizational skills, verbal and written communication skills
Ability to work independently as well as in a team environment
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 firstname.lastname@example.org to arrange for such an accommodation.
Job ID: R1116405
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