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    Senior Quality Specialist, Sequencing

    Katalyst Healthcares & Life Sciences
    5+ years
    Not Disclosed
    Remote, USA
    12 Nov. 21, 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: Senior Quality Specialist, Sequencing
    Company: Katalyst Healthcares & Life Sciences
    Location: Belmont, CA & Pleasanton, CA
    Contract Type: Contract

    Company Overview:

    Katalyst Healthcares & Life Sciences is hiring entry-level candidates for various contract research positions in Clinical Trials for drugs, biologics, and medical devices. We have several immediate job opportunities available in Drug Safety, Pharmacovigilance, and Clinical Research. We collaborate with university hospitals, pharmaceutical companies, and recruiting partners to advance healthcare innovations.

    Job Description:

    We are seeking a Senior Quality Specialist, Sequencing to support our Global Quality and Regulatory functions and various Sequencing Unit teams. This role will focus on quality management systems (QMS), ensuring compliance with FDA regulations, ISO standards, and Roche corporate requirements. The ideal candidate will have experience in quality systems, document management, CAPA management, and supplier quality, with the ability to identify and drive process improvements.

    Primary Responsibilities:

    • Develop and implement Quality Management System (QMS) elements and infrastructure/tools to ensure compliance with FDA QSR, ISO, and Roche corporate requirements.
    • Provide quality support for Document Management, Training Management, Supplier Quality, CAPA management, and Post Market Surveillance.
    • Write and revise Quality Systems procedures and assist with gap assessments and remediation actions.
    • Analyze QMS processes and develop procedures to drive compliant implementation.
    • Lead and execute process improvement activities.
    • Operate independently, meeting timelines and proactively fulfilling tasks.
    • Travel to Belmont, CA (3-4 days/week) and Pleasanton, CA (1-2 days/week).

    Qualifications:

    • Bachelor's degree in Biological Sciences, Engineering, or related field, or equivalent experience.
    • At least 5 years of experience in the medical diagnostic/device industry, focusing on quality systems and/or operations.
    • Exposure to software development is a plus.
    • Certifications such as ASQ CQM, CQE, CQA, or Six Sigma Black Belt are preferred.
    • Working knowledge of regulations including 21 CFR 820, ISO 13485, IEC 62304, and ISO 27001.

    Competencies:

    • Passion for contributing to the development of new products in a startup environment.
    • Ability to adapt to changing priorities and drive continuous improvement.
    • Strong leadership, interpersonal, and problem-solving skills with the ability to collaborate effectively across diverse teams.
    • Excellent organizational and analytical skills, with the ability to prioritize and manage multiple tasks.
    • Ability to engage with senior executives, contractors, and colleagues effectively.

    Additional Information:

    • Strong project management skills.
    • Excellent verbal and written communication skills.
    • Exceptional ability to discuss data and contribute to internal/external discussions.
    • Analytical & numerical skills to drive insights.

    Apply Now: Katalyst Healthcares Careers

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