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.
Assist in the establishment and monitoring of local laboratory quality and technical systems including assay quality control, proficiency testing review, assay validations, instrument qualification and/or the scientific database, collaborating with Global Lab Harmonisation, Assay Development Laboratory, Scientific Review, Data Management and Quality Assurance, Information Technology teams and Vendors as necessary in the execution and fulfillment of duties. Perform work in accordance with ICH E6 Guideline for Good Clinical Practice.
- Provide input into Global Laboratory Harmonisation and assists senior staff and other relevant parties with the review of local laboratory requirements for new studies, responding to technical inquiries and the provision of technical documents and data either directly or by maintaining study specific databases.
- Assist in monitoring the local Technical Support Helpdesk and in responding to inquiries from other departments and clients requesting specific laboratory information.
- Assist with quality control through maintaining the local laboratory Quality Control Program and database perform statistical analysis of data and quality control performance data reviews and the purchase and distribution management of quality control materials in accordance with Global Laboratory Harmonisation policy and regulatory guidelines.
- Provide input into Global Laboratory Harmonisation and assists with (new) assay validation through statistical analysis of data, troubleshooting, effective implementation of analytical methods and provision of technical information to relevant parties.
- Assist with all aspects and phases of proficiency testing and accreditation programs in the local laboratory, including but not limited to enrollment, submission/review and investigations.
- Assist with data analysis for performing linearity and comparison studies in the local laboratory or other studies as required by various agencies and/or as requested by sponsors.
- Assist with performing system lifecycle activities and associated deliverables pertaining to local laboratory instruments and equipment, including but not limited to the testing, and execution of validation activities, calibration, maintenance, change control, retirement activities, the renewal of laboratory instrumentation and equipment service contracts as well as assisting on-site vendor maintenance procedures per contract agreement.
- Provide input into Global Laboratory Harmonisation and may assist in the drafting of new standard operating procedures (SOPs) and the maintenance of existing SOPs related to the departmental activities.
- Represent Technical Services team in local audits/inspections from regulatory agencies and pharmaceutical sponsors
- Working knowledge of clinical laboratory regulations, GxP and /or ICH guidelines
- Working 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
- Bachelor's degree
- 5+ years of experience
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.
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