Laboratory QC Manager (R1102046) in San Juan Capistrano, CA at IQVIA™

Date Posted: 10/22/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    10/22/2019
  • Job ID:
    R1102046

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.

Essential Functions

• Manage the Quality Control (QC) support to operations.  Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development, rewarding and disciplining employees; recruiting; addressing employee relations issues and resolving problems.  Approve actions on human resource matters.

• Manage the review and development of technical and QC SOPs to ensure compliance with appropriate regulations.

• Lead QC staff meetings and discuss findings and recommendations for resolving non-compliance.

• Work closely with operation individuals to improve quality systems.

• Communicate progress and strategic planning to IQVIA management in clear and concise appraisal with recommendations.

• May perform QC review of Reports, Sample Login binders, run binders, Extraction paperwork, Lab notebooks, and data tables. Actively participate in QC educational programs: in-house workshops, presentations on current QC issues, QC training and QC Seminars for all new employees, etc.

• Track and report deviation trends to management.

• Utilize root cause analysis to evaluate all systems for gaps, recommend action and professionally communicate to management the analysis to continually improve quality.

• Design, develop and implement new QC procedures.

• Demonstrate continuous self-motivated quality development.

• Proactively take steps to improve quality systems.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Experience

Typically requires a minimum of 3 - 5 years of prior relevant experience.

Knowledge

Understands basic management approaches such as work scheduling, prioritizing , coaching and process execution.

Education

Bachelor's Degree Required

Additional Work Experience

7 years’ relevant experience in a quality / laboratory environment, including  GLP and/or Quality Assurance experience Required

or

Equivalent combination of education, training and experience

Skills and Abilities

Laboratory experience in a GLP environment.

Knowledge of word-processing, spreadsheet, and database applications.

Knowledge of GLP regulations and guidelines and advanced quality review techniques..

Strong interpersonal skills.

Excellent problem solving skills.

Effective organization, communication, and team orientation skills.

Ability to initiate assigned tasks and to work independently.

Ability to manage multiple projects.

Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Ability to manage staff

Strong training capabilities.

Standard ADA Settings

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

Standard ADA Selection  Lab Environment

Physical Demands

Frequently Sitting and Repetitive Motions

Working Environment

While performing the duties of this job, the associate is required to meet the following physical demands:

Working Indoors

Exposure to Extreme Cold

Exposure to Fumes/Dust/Dirt/Smoke

Working at Heights

Working around Equipment in Motion

Driving/Operating Mobile Equipment

Use of Hand Tools (power or manual)

Use of Personal Protective Equipment

Use of Office Equipment (computer, printer, telephone, etc.)

Travel Requirements

Travel as required.

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: R1102046