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Pre-Analytical and Sample Management Operations Quality Manager (R1070031) in Valencia, CA at IQVIA™

Date Posted: 3/11/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Valencia, CA
  • Experience:
    Not Specified
  • Date Posted:
    3/11/2019
  • Job ID:
    R1070031

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.

PURPOSE

The Quality Manager is expected to lead, support and coordinate efforts that foster quality and ensure that all processes are consistent with the company values and mission.

RESPONSIBILITIES

Duties may include but are not necessarily limited to the following:

  • Responsible for the oversight and management of the Quality proposition including but not limited to Correction Action and Preventive Actions (CAPA), Quality Issues (Qis), Trainings, Compliance, Process Review and Enhancements.
  • Evaluate, monitor and lead the department in developing robust processes in all functional areas and to track performance and metrics.
  • Responsible for ensuring appropriate Quality Control and Quality Assessments practices are performed throughout the departments.
  • Adhere to the CAPA & QI life cycle turnaround (TAT) requirements to ensure 100% compliance with established timelines in Standard Operating Procedure (SOP).
  • Supports all regulatory agencies inspections or assessments (College of American Pathologists, International Organizations for Standardization's Technical Committee ISO15189, New York State, , Clinical Laboratory Improvement Amendments CLIA)
  • Collate all quality metrics into a monthly assessment and present during the Quality Management meetings
  • Conduct Quality review and CAPA management meetings on a pre-defined cadence with required participation by all Pre-Analytical and Biorepository Operations CAPA owners and SMEs.
  • Lead formulation of responses to audit findings, entering the information into the Quality Tracking system and ensure that all CAPAs are implemented by the defined target date with evidence of completion.
  • Create effective materials (e.g., graphs, charts, training documentation) to promote Quality Improvement and present plans and results at Quality meetings, administers monthly Quality training/seminars for the Pre-Analytical/Biorepository Operations personnel

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Expert level Computer skills required (word processing, spread sheets, etc.).
  • Knowledge of word-processing, spreadsheet, and database applications.
  • Excellent verbal and written communication skills. Knowledge of Pre, Post and Analytical areas and safety procedures.  
  • Ability to establish and maintain effective working relationships with coworkers, managers, clients.
  • Effective organization, communication, and team orientation skills.
  • Positive interaction skills, attention to detail, and organizational skills
  • Ability to initiate assigned tasks and to work independently.
  • Ability to handle and manage multiple tasks/projects and to follow through with completion of assigned tasks with minimum supervision
  • Awareness of basic Good Clinical Practices (GCP) and Good Clinical Laboratory Practices (GCLP) requirements
  • Ability to learn scientific, medical, and regulatory terminology to gain an understanding of Quality data 

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • B.S or B.A degree (chemical, physical, biological or clinical laboratory science or medical technology), required.
  • Minimum of 3-5 years’ experience in clinical laboratory setting Minimum 2 years Quality Improvement and/or auditing experience
  • Previous Supervisory experience, preferred
  • Demonstrated success in managing/completing complex projects
  • Certified Quality Improvement Associate or Certified Quality Auditor (ASQ or equivalent), required

PHYSICAL REQUIREMENTS         

  • Extensive use of keyboard requiring repetitive motion of fingers. Use of telephone and face-to-face communication requiring accurate perception of speech. Regular sitting for extended periods of time.


Job ID: R1070031