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    Sr. Gcp Qa Auditor - Remote

    Medpace
    3+ years
    Not Disclosed
    Dallas
    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 Title: Quality Assurance (QA) Auditor

    Job Summary:

    Due to our rapid growth, we are seeking experienced industry professionals to join our Quality Assurance (QA) team. This role will support and audit global trials across various therapeutic areas while maintaining organizational and regulatory standards. The success of our QA department relies on the finely tuned skills and expertise of our QA Auditors.

    Responsibilities:

    • Act as a Quality Program Lead on clinical trials, ensuring compliance with 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.
    • Independent thinking and planning abilities.
    • Knowledge and application of Good Clinical Practice (GCP) is required.
    • Experience with Medical Devices and/or Phase 1 trials is a plus.
    • Ability to travel 30%-40% of the time.
    • Excellent written and verbal communication skills.
    • Exceptional teamwork and independent working abilities.

    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 major areas, including oncology, cardiology, metabolic disease, endocrinology, CNS, 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.

    Our work over the past 30+ years has positively impacted the lives of countless patients and families facing various diseases. The efforts we make today will improve the lives of those living with illness and disease in the future.

    Dallas Perks:

    • Hybrid work-from-home options (dependent on position and level).
    • Competitive PTO packages starting at 20+ days.
    • Competitive compensation and benefits package.
    • Flexible work schedule.
    • Company-sponsored employee appreciation events.
    • Employee health and wellness initiatives.
    • Community involvement with nonprofit organizations.
    • Structured career paths with opportunities for professional growth.
    • Discounts on local sports games, gyms, and attractions.
    • Modern, eco-friendly campus with an on-site fitness center.
    • Free on-site parking and outdoor seating/workspace.

    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 awarded CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.

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