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    Associate Compliance Specialist, Quality Event Management

    Thermo Fisher Scientific
    0-5 years
    Not Disclosed
    Remote Remote - Europe Remote, USA
    10 Oct. 17, 2024
    Job Description
    Job Type: Full Time Remote 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

    Job Description: Quality and Compliance Support Specialist

    Summarized Purpose:
    Supports and implements quality and compliance processes, facilitates tracking and reporting of activities, maintains tools and materials, and provides expertise to advance the department's vision.

    Job Requirements:

    • Research and address issues using problem-solving methodologies, documenting in accordance with ALCOA principles and compliance metrics related to quality activities.
    • Ensure appropriate 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 for compliance activities (e.g., client audits, CAPA, and procedural documents).
    • Develop support materials, presentations, and tools to support departmental strategies.

    Job Complexity:

    Works on diverse problems with subject matter input, appropriate data management, and requires strong problem-solving skills.

    Job Knowledge:

    An experienced professional with a comprehensive understanding of the specialization; resolves a wide range of issues creatively.

    Supervision Received:

    Normally receives detailed instructions on all work.

    Business Relationships:

    Represents the department as a primary contact on projects, interacts with internal and external personnel on significant matters, and networks with senior collaborators in their area of expertise.

    Qualifications:

    Education and Experience:

    • Bachelor’s degree or equivalent relevant formal qualification.
    • Previous experience providing the knowledge, skills, and abilities to perform the job (0 to 2 years). An equivalency of education, training, and/or related experience may also be considered.

    Knowledge, Skills, and Abilities:

    • Effective oral and written communication skills in English.
    • Strong prioritization and time-management skills.
    • Knowledge of the clinical trial process and understanding of ICH GCP and other relevant regulations.
    • Demonstrated problem-solving skills, including root cause analysis and corrective/preventive actions.
    • Strong attention to detail and computer skills; ability to learn and use appropriate software.
    • Ability to prioritize tasks for efficient workload management.
    • Flexibility and adaptability in changing conditions.
    • Strong judgment, decision-making, issue, and risk management skills.
    • Creative and critical thinking abilities.

    Management Role: No management responsibility.

    Working Conditions and Environment:

    • Work performed from a remote home-based 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 simple tasks.
    • Light to moderate lifting (15-20 lbs).
    • Proficient in a variety of computer software.
    • Effective communication skills and ability to listen and understand spoken information.
    • Frequent cross-functional interaction for information acquisition.
    • Works independently with moderate guidance, planning schedules to meet goals.
    • Performs a variety of tasks with changing demands and conditions.
    • Ability to perform under stress and multitask.
    • Regular and consistent attendance.

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