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    Associate Compliance Specialist, Quality Event Management

    Thermo Fisher Scientific
    0-2 years
    Not Disclosed
    Remote Remote - Europe Remote, USA
    10 Oct. 25, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    The Quality Difference

    At Thermo Fisher Scientific, our quality teams share a passion for getting it right the first time, always with our customers in mind. Our Quality professionals understand the critical importance of accuracy, safety, and effectiveness in our products and services that improve lives worldwide. By joining our team, you'll collaborate on global projects while being encouraged to develop your skills and explore new career paths.

    Work Schedule

    • Standard (Mon-Fri)

    Environmental Conditions

    • Office-based

    Job Description

    Summarized Purpose: Supports and implements quality and compliance processes, facilitating the tracking and reporting of activities. Maintains tools and materials while offering expertise to advance the department’s vision.

    Key Responsibilities

    • Research and address issues using problem-solving methodologies, documenting in accordance with ALCOA principles and metrics related to quality activities.
    • Ensure proper execution and completion of quality processes.
    • Participate in small to medium-scale process improvement initiatives.
    • Communicate with representatives from other departments to maintain quality and timelines concerning compliance activities (e.g., client audits, CAPA, and procedural documents).
    • Develop support materials, presentations, and tools to aid department strategies.

    Job Complexity

    Works on diverse problems requiring subject matter input and good problem-solving skills.

    Job Knowledge

    An experienced professional with a full understanding of the area of specialization, capable of resolving a wide range of issues creatively.

    Supervision Received

    Normally receives detailed instructions on all work.

    Business Relationships

    Represents the department on projects, interacting with internal and external personnel on significant matters that require coordination between functional areas. Networks with senior collaborators in their area of expertise.

    Qualifications

    Education and Experience:

    • Bachelor’s degree or equivalent relevant academic/vocational qualification.
    • Previous experience providing the knowledge, skills, and abilities to perform the job (0 to 2 years).

    In some cases, a combination of appropriate education, training, and/or directly related experience may be considered sufficient.

    Knowledge, Skills, and Abilities

    • Effective oral and written communication skills in English.
    • Strong prioritization and time-management abilities.
    • Knowledge of the clinical trial process and understanding of ICH GCP and relevant regulations.
    • Proven problem-solving skills, including root cause analysis and corrective/preventive actions.
    • Strong attention to detail and computer proficiency.
    • Demonstrated ability to prioritize tasks for efficient workload management.
    • Flexibility and adaptability in various situations.
    • Effective judgment, decision-making, and issue/risk management skills.
    • Strong creative and critical thinking abilities.

    Management Role

    No management responsibility.

    Working Conditions and Environment

    • Work performed from a remote home office environment with exposure to electrical office equipment.

    Physical Requirements

    • Ability to work in an upright and/or stationary position for 6-8 hours per day.
    • Repetitive hand movements for fast, simple, repeated actions.
    • Light to moderate lifting (15-20 lbs) and carrying of objects, including luggage and a laptop.
    • Proficiency with various computer software, both in-house and off-the-shelf.
    • Strong communication skills for understanding and conveying information.
    • Frequent cross-functional interaction to acquire related information.
    • Ability to work independently with moderate guidance, planning work schedules to meet goals.
    • Capability to perform under stress and multitask.
    • Regular and consistent attendance is required.

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