QC Analyst

Guerbet SA
  • Raleigh, NC
    8 days ago

    Job Description

    QC Analyst

    At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

    We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

    Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.

    Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

    For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

    WHAT WE ARE LOOKING FOR

    The QC Analyst operates in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization's framework, company's procedures, and the defined scope of responsibility the role is accountable for.

    The QC Analyst performs routine and non-routine laboratory testing in compliance with applicable safety, quality, and regulatory standards. This role demonstrates increased technical proficiency, independence, and problem-solving capability, supporting laboratory operations including finished product and raw material testing, investigations, and continuous improvement within a cGMP-regulated environment.

    YOUR ROLE

    • Performs routine and advanced laboratory testing, including wet chemistry, analytical assays, and raw material testing, in accordance with approved SOPs
    • Accurately records, analyzes, and reports laboratory results in compliance with data integrity (ALCOA+) standards
    • Identifies, documents, and reports out-of-specification (OOS), out-of-trend (OOT), or atypical results
    • Independently supports and contributes to investigations, including root cause analysis and documentation
    • Reviews data for accuracy, completeness, and compliance with procedures
    • Maintains, troubleshoots, and ensures proper functionality of laboratory instrumentation
    • Authors and revises SOPs, test methods, and laboratory documentation as needed
    • Participates in method verification, method transfer, validation activities and raw material qualification support under limited supervision
    • under limited supervision
    • Performs sampling, testing, and evaluation of raw materials and components in accordance with specifications and compendial requirements
    • Follows GMP, safety, and regulatory requirements to maintain compliance and audit readiness
    • Collaborates with manufacturing, formulation, packaging, and QA teams to support production and quality objectives
    • Supports sample management activities (receipt, labeling, storage, and tracking)
    • Actively participates in training, cross-training, and continuous improvement initiatives
    • May provide guidance and training to junior analysts
    • Performs other duties as assigned by management

    YOUR BACKGROUND

    Required Qualifications:

    • Bachelor's degree in chemistry or related scientific field (or equivalent experience)
    • 4+ years of laboratory or analytical experience with demonstrated technical proficiency (GMP environment preferred)

    Preferred Qualifications:

    • Working knowledge of cGMP, USP, and regulatory expectations
    • Hands-on experience with raw material testing, specification evaluation, and/or incoming material inspection activities
    • Experience with analytical instrumentation (e.g., HPLC, GC, dissolution, spectroscopy)
    • Experience with laboratory systems (e.g., LIMS, Empower/CDS)
    • Demonstrated ability to support investigations, method activities, and technical problem-solving

    Reason to join US

    Much more than a Competitive salary,

    We offer continued personal development. When you join Guerbet, you :

    • Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
    • Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world,
    • Are joining a company where we value diversity of talents coming from various horizon.

    We # Innovate # Cooperate # Care #Achieve at Guerbet.

    Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

    Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com or you can also call this number +19843443717

    Numbers & Facts

    LocationRaleigh, NC

    Skills

    • Analysis Skillsunmatched
    • Analytical Chemistryunmatched
    • Artificial Intelligence (AI)unmatched
    • Assaysunmatched
    • Biotech and Pharmaceuticalunmatched
    • Chemistryunmatched
    • Continuous Improvementunmatched
    • Current Good Manufacturing Practice (cGMP)unmatched
    • Data Qualityunmatched
    • Diagnostics Solutions/Softwareunmatched
    • Diversityunmatched
    • Documentationunmatched
    • GMP (Good Manufacturing Practices)unmatched
    • High Performance Liquid Chromatography (HPLC)unmatched
    • Identify Issuesunmatched
    • Instrumentationunmatched
    • Laboratoryunmatched
    • Laboratory Analysisunmatched
    • Laboratory Information Management System (LIMS)unmatched
    • Laboratory Operationsunmatched
    • Laboratory Systemsunmatched
    • Laboratory Testingunmatched
    • LinkedInunmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Materials Analysisunmatched
    • Materials Testingunmatched
    • Medical Equipmentunmatched
    • Medical Imagingunmatched
    • Multiculturalunmatched
    • Operational Supportunmatched
    • Patient Careunmatched
    • People Managementunmatched
    • Problem Solving Skillsunmatched
    • Production Supportunmatched
    • Quality Assuranceunmatched
    • Quality Assurance Methodologyunmatched
    • Quality Controlunmatched
    • Quality Managementunmatched
    • Quality of Lifeunmatched
    • Record Keepingunmatched
    • Regulationsunmatched
    • Regulatory Requirementsunmatched
    • Research & Development (R&D)unmatched
    • Root Cause Analysisunmatched
    • Safety Complianceunmatched
    • Safety Trainingunmatched
    • Safety/Work Safetyunmatched
    • Specimens/Samplesunmatched
    • Spectroscopyunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Test Labunmatched
    • Testingunmatched
    • Training/Teachingunmatched
    • Twitterunmatched
    • YouTubeunmatched

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