• Quality Validation Analyst

    Job Locations US-PA-Plymouth Meeting, PA. USA
    Job ID
    2019-3305
    Category
    Quality Assurance
    Position Type
    Permanent Employee - Full-Time
  • Role Overview

    Quality Validation Analyst, Plymouth Meeting, PA

     

    The Validation Analyst is responsible for understanding software validation in a government regulated environment with special attention to the Software Development Lifecycle (SDLC) validation processes which meet regulatory requirements.

    The Validation Analyst ensures that all study work is conducted to CRF-Bracket’s procedures and processes and supports the CRF-Bracket Validation Methodologies. The goal of the Validation Analyst is to foster and promote quality throughout the SDLC/PLC.

    The position requires a high level of integrity as this person is working on a client’s project and preparing documents that may be submitted to regulatory agencies (FDA, EMEA etc.) as needed, and actions impact the quality and reliability of the client's’ product.

     

    Key Accountabilities/Decision Making & Influence

     

    • Work with internal staff in implementation of improved capabilities in the areas of documentation
    • Assist in performing analysis of current validation situations, review internal controls.
    • Propose validation improvement suggestions.
    • Compose and document validation strategies; Validation Plans, Validation Summary Reports, and other validation documents as needed.
    • Collaborates with other departments to ensure validation activities are executed in a compliant fashion
    • Interface with Client Services, Technical Delivery, QA, and Support Staff to ensure compliance with the SDLC/PLC.
    • Review documentation for accuracy and completeness, tracking and driving completion of Validation milestones per the project schedule.
    • Creation of detailed Validation execution schedules.
    • Interface with Project controls.
    • Attend project meetings.
    • Providing quality oversight, cross-checks and approvals

    Knowledge, Skills & Attributes

     

    Education

    • Bachelor’s degree or commensurate experience

    Experience

    • At least 1 year of work experience supporting multiple projects/processes in a fast-paced work environment.

    Competencies and Personal Attributes

    • High degree of self-motivation and attention to detail.
    • Superior verbal/written communication and interpersonal skills including the ability to deliver information effectively and facilitate team processes in person and via telephone or e-mail.
    • Ability to work collaboratively and take direction from multiple inputs.
    • Ability to manage and meet multiple deadlines and respond to multiple requests for support.
    • Proficient computer skills including Word, Excel, Outlook and PowerPoint. Familiarity with Visio preferred.
    • Ability to quickly learn and apply new skills, procedures and approaches.
    • Demonstrated ability to meet very short deadlines & multi-task in an extremely fast-paced work environment with little direct supervision.
    • Proven ability to work in a team-oriented environment, providing back-up support to team members & establishing/maintaining effective work relationships with co-workers within and across functional areas.
    • Previously demonstrated proactive and positive approach to tasks and projects overall, as well as to the types of scheduling and process changes that are inherent in a fast-paced business. 

     

    About CRF Health

    Global Leader in eCOA Solutions

     

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    CRF Health is a global leader in eCOA (electronic Clinical Outcome Assessments) solutions for the life sciences industry. eCOA encompasses PROs (Patient Reported Outcomes), ObsROs (Observer Reported Outcomes) and ClinROs (Clinician or Rater Reported Outcomes) with outstanding project management focused on delivering value for our customers.  Committed to driving the change to higher quality outcomes and more efficient paper-free clinical trials through improved patient engagement, our intuitive and patient-focused eCOA technology helps companies bring new medicines to market quickly, safely and more cost-effectively. Our complete eCOA solutions are ideal for home and site-based phase I-IV clinical trials across the world for many therapeutic areas and patient populations.  More information can be found on our website.  

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