Associate Lab Quality Manager (R1097054) in Valencia, CA at IQVIA™

发布日期: 2/17/2020

职位快速浏览

  • 员工类型:
    Full-Time
  • 地点:
    Valencia, CA
  • 经验:
    Not Specified
  • 发布日期:
    2/17/2020
  • Job ID:
    R1097054

职位描述

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.

PURPOSE

Provide Quality Assurance guidance to the Laboratory Operational team to ensure compliance and timely CAPA responses. Familiar with Quality tools such as root cause analysis, FMEA, CAPA planning and effectiveness checks. Support establishment of a quality culture in the laboratory through mentoring and regular monitoring. Performs work in accordance with ICH E6 Guideline for Good Clinical Practice.

RESPONSIBILITIES

  • Support monitoring compliance with CAP and ISO 15189 regulations through the performance of inspections in all laboratory departments to assess Quality Control processes and records.
  • Monitor progress of Quality Issues/CAPAs and ensure timely entries in EDA by CAPA owners.
  • Monitor Lab departmental compliance with required training plans and SOP acknowledgements.
  • Support Managers to provide basic lab training sessions, and to ensure GDR compliance.
  • Support problem-solving and resolution efforts in a timely, customer focused manner.
  • Support implementation of training monitoring system and support rollout to other regions.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Bachelor's Degree in medical technology or equivalent required and  3-5 years’ experience in a research laboratory/clinical laboratory environment required  or equivalent combination of education, training and experience
  • Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.
  • Knowledge of clinical laboratory regulations and/or ICH guidelines.
  • Knowledge of laboratory equipment, clinical laboratory assays, quality control and validation procedures.
  • Excellent attention to detail, organizational skills, verbal and written communication skills
  • Ability to balance multiple priorities
  • Ability to establish and maintain effective working relationships with coworkers, managers, clients and auditors.
  • Working knowledge of quality assurance and quality control principles.
  • Strong written and verbal communication skills.
  • Good presentation skills and the ability to impart complex data and process to a wide audience.

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: R1097054