This site uses cookies. To find out more, see our Cookies Policy

Lab Equipment Validation Lead (R1079786) in Valencia, CA at IQVIA™

Date Posted: 6/11/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Valencia, CA
  • Date Posted:
    6/11/2019
  • Job ID:
    R1079786

Job Description

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.

Job Profile Summary

Act as a lead for the local laboratory quality and technical systems including validation, quality control, proficiency testing, metrology and/or technical support aspects of the local clinical laboratory, collaborating with Global Harmonisation, Assay Development Laboratory, Scientific Review, Data Management, Quality Assurance, Information Technology teams and Vendors as necessary in the execution and fulfillment of duties.

Responsibilities

Essential Functions

  • Mentor new hires within the department. Responsible for the completion of competency forms and associated documentation related to their training activities.
  • Experience leading qualification and validation (IQ, OQ, PQ) process in regards to laboratory equipment/instruments
  • 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 sponsors.
  • •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 highest standard.
  • 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 laboratory

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor's Degree in life sciences and 3 years relevant clinical laboratory experience or Equivalent combination of education, training and experience
  • Experience with ICH GCP E6, ISO 15189, computer system validation principles and 21 CFR Part 11 highly preferred

Skills and Abilities

  • Knowledge of clinical laboratory regulations, GxP and /or ICH guidelines
  • Experience with laboratory equipment/instruments qualification and validation (IQ, OQ, PQ)
  • 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

Physical Demands

  • Sit at a desk or table with some walking, standing, bending, stooping, or carrying of light objects.
  • Perform continuous operation of a personal computer for four hours or more.

The above information on this description has been designed to indicate the general nature and level of work performed. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, qualifications and working conditions required of employees assigned to this job. While this is intended to be an accurate reflection of the job, management reserves the right to revise the job at any time.

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 workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1079786