Iqvia Holdings Inc Valencia , CA 91354
Job Description: Launched in 2015, Q2 Solutions is a leading global clinical trials laboratory services organization. We help biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. Q2 Solutions is a quality driven, responsive partner with strong global experience and deep scientific and medical expertise. The Q2 Solutions joint venture was formed by Quintiles and Quest Diagnostics, combining the best of each parent organizations clinical trials laboratory services capabilities.
Responsible for the review and reporting of Anatomic Pathology samples in accordance with applicable regulations governing clinical laboratories. This position will be working in conjunction with DPMG.
Review and report surgical pathology and cytology samples including routine H&E staining, Immuno-histochemistry and FISH assays on a daily basis.
Ensure reporting is completed within the TAT required for the assay/ study.
Comply with the international standards for scoring of the assays and participate in peer review programs, CAP proficiency surveys on a regular basis.
Participate in the development and validation of new assays in the AP lab with review and interpretation of results for new assays on a regular basis. Involved in trouble shooting and resolution of technical issues related to assay protocol.
Participate in the training sessions with pharma and other diagnostic partners for scoring of new assays leading to certification and subsequent analysis of patient samples.
Participate in sponsor discussions for new study requests and / or new assay development as and when required.
Participate in scientific review for new study requests, provide pathologist expertise and input for the study requirements as and when required.
Ensure that the highest standards of quality and customer service are maintained. Collaborate with Quality Assurance staff on development and implementation of effective programs. Monitor outside proficiency testing program as required; take corrective action promptly when results are unsatisfactory.
Establish effective staff selection and training program to ensure that qualified staff are hired and continuously trained in order to remain current on testing procedures.
Keep abreast of new technical developments. Implement new tests, equipment, programs and/or procedures in the department as needed. Lead continuous improvement initiatives to increase quality of services and operational efficiency.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
In depth knowledge of clinical testing procedures and applicable laboratory testing regulations
Working knowledge of quality assurance and quality control principles and in depth knowledge of company-specific program requirements
Knowledge of occupational safety and health rules and regulations
Excellent written and oral communication skills
Excellent client management and problem resolution skills
High ethical standards
Ability to assess and prioritize multiple tasks, projects and demands
Ability to establish and maintain effective working relationships with co-workers, managers and clients
Job Requirements MINIMUM REQUIRED EDUCATION AND EXPERIENCE
MD with Board certification in Anatomic Pathology with a strong interest in Molecular Pathology and the development of new diagnostics.
Applicable certifications and licenses as required by country, state, and/or other regulatory bodies
Experience in Molecular Pathology is an advantage.
Experience as an Anatomic Pathologist in either hospital or pharmaceutical industry is an advantage.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Extensive use of microscope
Please note this is a full-time position, Monday-Friday.
EEO Minorities/Females/Protected Veterans/Disabled
Job ID: 1808310
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