Signant Health

  • Quality Analyst Associate

    Job Locations UK-LND-Hammersmith
    Job ID
    2019-3314
    Category
    Quality Assurance
    Position Type
    Permanent Employee - Full-Time
  • Role Overview

    Quality Analyst Associate 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.

     

    Quality Analyst Associate ensures that all study work is conducted to Signant Health's procedures and processes and supports the Signant Health Validation Methodologies. 

     

    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

     

    Essential Duties and Responsibilities:

    • 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    IND1

    Knowledge, Skills & Attributes

    Skills & Competencies

     

    Education

    • Bachelor’s degree or commensurate experience

    Experience

    • At least 1 year of work experience
    • Good understanding of good clinical practice
    • Supporting multiple projects/processes in a fast-paced work environment.

     

    Competencies & 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.

     

     

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