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    Sr. Gcp Qa Auditor - Remote

    Medpace
    5+ years
    Not Disclosed
    Remote
    10 Oct. 23, 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

    Job Summary
    Due to our rapid growth, we are seeking experienced industry professionals to join our Quality Assurance (QA) team. This position will support and audit global trials across various therapeutic areas, ensuring compliance with organizational and regulatory standards. As a vital member of our Quality Assurance department, your expertise will be crucial to our success.

    Responsibilities

    • Act as a Quality Program Lead on clinical trials, ensuring adherence to national and international regulatory standards for pharmaceuticals, biologics, and medical devices.
    • Develop audit management plans and strategies in collaboration with clients for ongoing clinical trials.
    • Coordinate and conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines.
    • Participate in the development of departmental standard operating procedures, work instructions, forms, and templates.
    • Assess the validated state and security of proprietary and cloud-based software.
    • Develop training materials and interactive tests, including company-wide regulatory training (ICH/GCP).

    Qualifications

    • Bachelor’s degree in life sciences or a related field.
    • 5+ years of experience in a QA department within a related industry.
    • Experience conducting audits of vendors and investigative sites.
    • Experience hosting regulatory authorities and interacting with sponsor/client representatives.
    • Strong independent thinking and planning abilities.
    • Comprehensive knowledge and application of Good Clinical Practice (GCP).
    • Experience with medical devices and/or Phase 1 trials is a plus.
    • Ability to travel up to 30%-40% of the time.
    • Excellent written and verbal communication skills.
    • Exceptional teamwork skills and the ability to work independently.

    Medpace Overview
    Medpace is a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas, including oncology, cardiology, metabolic disease, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ over 5,000 people across 40+ countries.

    Why Medpace?
    People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

    The work we’ve done over the past 30+ years has positively impacted countless patients and families facing various diseases across key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

    Medpace Perks

    • Hybrid work-from-home options (dependent upon position and level)
    • Competitive PTO packages starting at 20+ days
    • Company-sponsored employee appreciation events
    • Employee health and wellness initiatives
    • Flexible work schedule
    • Competitive compensation and benefits package
    • Structured career paths with opportunities for professional growth
    • Discounts for local businesses

    Awards

    • Named a Top Workplace in 2024 by The Cincinnati Enquirer
    • Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024
    • Continually honored with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.

    Join Medpace and make a difference!

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