北京招聘

PURPOSE
Serves as the lead Technical Laboratory Specialist in the development and maintenance of various support systems which will provide process improvements for the Laboratory department and other groups.

RESPONSIBILITIES
？ Participates in the drafting of new standard operating procedures (SOPs), Technical bulletins and the maintenance of existing SOPs related to the departmental activities on both a regional or global basis.
？ Participates in audits/inspections from regulatory agencies and pharmaceutical sponsors.
？ Actively communicate with technical counterparts located at other facilities throughout the organization to ensure harmonization.
？ Provides troubleshooting techniques for difficult methods or methods which have developed some analytical imprecision which may adversely affect the assay performance.
？ Leads in the design, performance and evaluation of sample stability studies as required.
？ Provides statistical analysis of data from all laboratory sites, certification studies, and other tasks as needed.
？ Develops and maintains an accurate Task List and provide Metrics related to assay validations, stability studies, QC, Proficiency surveys, and/or laboratory performance indicators.
？ Provides training on instrument validationss, assay validations, quality control, handling of proficiency surveys and/or accreditation scheme samples.
？ Develops and maintains a comprehensive validation program for all new instruments and new assays in accordance with regulatory guidelines. Responsible for all documentation related to assay validations.
？ Develops and maintains the development of schedules and completes data analysis for performing linearity and comparison studies, or other studies as required by regulatory agencies or as requested by sponsors. Responsible for all documentation related to biannual linearity and comparison testing.
？ Ensures all Technical Bulletins received in the laboratory are distributed in a timely manner for review by lab management and the global harmonization team.
？ Develops and maintain sa comprehensive quality control program for all active assays in accordance with regulatory guidelines. Maintains the laboratory’s Quality Control Database. Responsible for QC inventory, the global harmonization, purchase and distribution of quality control materials with other Quintiles worldwide laboratories.
？ Develops and maintains comprehensive proficiency testing survey and accreditation program for all active assays in accordance with regulatory guidelines.
？ Maintains effective communication with Project Management, Business Development and other departments with Quality Assurance checkpoints, process control and all project planning.
？ Actively participates in the Technical Review of laboratory requirements for new studies during the database design phase and validation.
？ Provides test code assignment, worksheets, specimen requirements and shipping conditions for database loads.
？ Performs laboratory's Dr. Validate process and reviews to ensure accuracy with new study designs.
？ Provides reference laboratory testing information to other departments.
？ Maintains the Test Catalog for analytes tested at regional lab locations for test codes, LOQ values, worksheets,
instrumentation, methodologies, etc.
？ Maintains the Technical support Helpdesk inquiries from other departments requesting specific laboratory information
and writing CQIP reports for sponsor inquiries, as required by Lab Management.
？ Actively participates in the Metrology program to include, but not limited to analytical and non-analytical equipment
maintenance, electrical checks and other mechanical functions, when necessary.
？ Serves as the Administrator for the calibration database system and for the temperature/building monitoring system.
？ Coordinates with on-site vendor maintenance procedures per contract agreements.
All responsibilities are essential job functions unless noted as nonessential (N).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
？ General knowledge of clinical laboratory regulations, GxP and /or ICH guidelines
？ Excellent attention to detail
？ Excellent written and verbal communication skills
？ Excellent organizational 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

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
？ Associate’s degree in metrology and 5 years relevant clinical laboratory experience or Bachelor's degree in life sciences
or other relevant field and 3 year relevant clinical laboratory experience; or equivalent combination of education, training
and experience

ABOUT THE COMPANY
Quintiles Transnational Corp. strives unceasingly to exercise strong LEADERSHIP in our industry and to be the unquestioned FIRST CHOICE Contract Pharmaceutical Organization in an increasingly competitive marketplace.
We will DELIGHT our CUSTOMERS world-wide with the fullest range and highest quality of information and services, and with a spirit and a DEDICATION that bring professional esteem and admiration.
We demand the utmost level of EXCELLENCE, CREATIVITY, and SKILL from all our staff and management so that we add value to our customers by driving to PERFORMANCE goals in ways that are quantifiable.
We thrive on continuous IMPROVEMENT and QUALITY enhancements through attention to detail,consistent feedback, state-of-the-art systems, TRAINING and TEAMWORK.
We seek unendingly to bring our customers'PRODUCTS and SERVICES to MARKET ever sooner and to play a creative role in their achievement of earlier and greater commercial SUCCESS.
Throughout our commercial pursuits, we will respect and hold in esteemed honor our EMPLOYEES, to whom we owe our very existence.
We will maintain and enhance our reputation and integrity by demanding the highest possible ETHICAL STANDARDS and demonstrate by example an unyielding dedication to employees, customers, vendors, and shareholders. A SHARED VISION of success among these stakeholders will enhance the quality of life for all people of the world as we vigorously pursue our mission in an era of unprecedented OPPORTUNITY