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Computer System Validation Specialist

Company: Advanced Clinical
Location: Chesterfield
Posted on: January 7, 2022

Job Description:

Overview
We are currently searching for a skilled professional to join a well-known client's team as a Computer System Validation Specialist in Westport, Missouri. The Computer System Validation Specialist role will provide technical and compliance expertise to support continuous improvement of departmental operating procedures and processes. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
Responsibilities

  • Provide technical and compliance expertise to write SDLC documentation in accordance with local procedures, templates, regulatory requirements (21 CFR Part 11, 211, 820), and IT Security Standards
  • Track and execute assigned computer system Periodic Reviews, User Account Reviews, and other computer system compliance processes
  • Assist in performing change control impact assessments and work with technical subject matter experts (SMEs)
  • Represent the department in site-level change control meetings
    Experience
    • Minimum of 3 years of experience in pharma/device or other regulated industry required
    • Proficient in English
    • Excellent knowledge in writing Validation Documents (Validation Master Plans, Validation Protocols, Associated SOPs, Part 11 Risk Assessments, Verification Plans, Test Scripts, etc.)
    • Demonstrated ability in completing project management or business analyst role projects according to prescribed timelines and requirements required
    • Strong work ethic with a positive attitude
    • Excellent listener with good verbal and communication skills
    • Ability to multi-task/multi-project with strong self-management, problem-solving, and time management skills
    • Experience with SDLC and other IT project management methodologies required, Agile development desired
    • Ability to exercise sound judgment and work effectively with a diverse workforce
    • Experience with lab systems, plant manufacturing systems, Document Management Systems, CAPA processes, and Learning Management Systems desired
      EDUCATION
      • Minimum of Bachelor's Degree in Computer Science, Information Technology, or other science-related discipline required
      • Lean Six Sigma certification and/or experience preferred
        To Be a Best-fit Your Strengths Must Include
        • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
        • Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
        • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
        • Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
        • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
        • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
          About Advanced Clinical
          Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality and Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent and Client, visit http://www.advancedclinical.com.
          Regarding your application
          Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
          It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
          498776

Keywords: Advanced Clinical, Chesterfield , Computer System Validation Specialist, IT / Software / Systems , Chesterfield, Missouri

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