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    Quality Systems Analytics Specialist

    Abbvie
    3-5 years
    Not Disclosed
    Branchburg Township
    10 July 15, 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, 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 Title

    Quality Systems Analytics Specialist

    Company

    AbbVie

    Location

    Branchburg Township, NJ, USA

    Benefits Offered

    • Dental
    • Medical
    • Paid Time Off
    • Retirement
    • Vision

    About AbbVie

    AbbVie's mission is to discover and deliver innovative medicines and solutions that address serious health issues today and tackle the medical challenges of tomorrow. We aim to make a remarkable impact on people's lives in key therapeutic areas such as immunology, oncology, neuroscience, and eye care, along with products and services in our Allergan Aesthetics portfolio. For more information, visit AbbVie and follow @abbvie on Twitter, Facebook, Instagram, YouTube, and LinkedIn.

    Job Description

    We are seeking a skilled Quality Systems Analytics Specialist to join our team at the Branchburg site. This role provides a unique opportunity to lead and foster a data-driven culture within our quality organization and site, reporting directly to the Executive Director of Quality.

    Responsibilities

    • Manage Critical Metrics:
      • Quality Index
      • Site Business Review
      • Quality Systems Management Review
      • Post Market Surveillance Review
    • Insights and Analysis:
      • Provide in-depth insights for each metric.
      • Understand context and drivers for any misses.
      • Represent Branchburg in above-site reviews.
    • Procedure Ownership:
      • Own and maintain procedures for Post Market Surveillance, Quality Management System Review, and other assigned procedures.
    • Data Management:
      • Extract data from various quality data systems as needed.
    • Culture Development:
      • Lead establishment of a metrics-driven culture.
      • Collaborate with stakeholders to understand data sources, limitations, and opportunities.
    • Standard Work Development:
      • Develop standard work and enhance skills.
      • Integrate metrics into tier structures to drive actions and share best practices.
    • Reporting and Tools Development:
      • Generate ad hoc reports and develop analytics tools.
      • Use visualization/BI tools to create automated dashboards.
    • Corrective Actions:
      • Collaborate cross-functionally to drive corrective actions and improve metrics.
      • Ensure key metrics are integrated into Tier and monthly review processes.
    • Complaint Trend Monitoring:
      • Collaborate cross-functionally on complaint trend monitoring and evaluation.
      • Generate and maintain Post-Market Surveillance Plans and Periodic Safety Update Reports for medical devices.
    • Compliance Monitoring:
      • Implement processes to ensure compliance with regulations and guidelines including FDA 21CFR 1271 and 820, ISO 9001 and 13485, EU MDR, Health Canada regulations, AATB, and state regulations.

    Qualifications

    • Education:
      • Bachelor's degree in Science, Business, Engineering, or related discipline, or equivalent work experience.
    • Experience:
      • 3-5 years in Medical Device, Pharmaceutical, Human Tissue, or other regulated industries.
      • 3-5 years in quality analysis, operations analysis, or other quality-related responsibilities.
    • Skills:
      • Knowledge in Quality Systems, Regulations, and Standards.
      • Data-driven with strong problem-solving skills and focus on continuous improvement.
      • Excellent communication skills (written and verbal) and attention to detail.
    • Software Proficiency:
      • Minitab, Power BI, Microsoft Office Suite (PowerPoint, advanced Excel including Power Query, pivot tables, complex formulas).
    • Preferred:
      • Familiarity with SAP and Global TrackWise.
      • Lean, Six Sigma training and expertise.

    Additional Information

    • Location:
      • Onsite at Branchburg, NJ.
    • Compensation:
      • The base pay range is subject to change and may vary depending on geographic location and other factors. Benefits include paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k).
      • Eligible for short-term incentive programs.
    • Company Policy:
      • AbbVie is committed to integrity, innovation, transforming lives, community service, and embracing diversity and inclusion. We employ qualified persons without discrimination based on race, color, religion, national origin, age, sex, disability, medical condition, genetic information, gender identity, sexual orientation, marital status, veteran status, or any other legally protected status.

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