QA Associate

Johnson & Johnson

4.2

Leiden, Netherlands

Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020

  • 4.2/5 in overall job satisfaction

  • 4.3/5 in supportive management

  • 72% say women are treated fairly and equally to men

  • 88% would recommend this company to other women

  • 85% say the CEO supports gender diversity

  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).

  • Global exercise reimbursement.

  • Two weeks off (one of them fully paid) for volunteer work.

  • #2306106675W

    Position summary

    We are looking for an enthusiastic and motivated colleague who will help us to strengthen our QA team of Janssen Biologics, somebody who would like to contribute to a high quality organization of the site and J&J. The main focus will be warehouse related quality issues, but can vary over time.

    The QA associate will be the linking pin in the investigations into quality issues and with that responsible for the improvement of the overall quality status.

    The activities are very dynamic and varied. The candidate likes challenges, doesn’t avoid problems and enjoys working is various teams.

    About the Company: Janssen Biologics B.V. is a multinational pharmaceutical company that has been for more than 25 years a leader in the field of biomedicines. Through the dynamic science of biotechnology, we continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders (I.M.I.D.s), such as rheumatoid arthritis and psoriasis. Janssen Biologics in Leiden is currently manufacturing COVID 19 vaccine (Drug Substance) vaccine. Janssen Biologics is part of the Johnson & Johnson family of companies. The department Quality Assurance sees to that quality systems are applied as per GMP standards within Janssen Biologics and is responsible for handling non-conformances, bulk (PFB / FB) and intermediate (DPC / CSS) release and change control. The QA department plays an important role in providing advice on quality topics to all departments of the supply chain.

    To fill in this phenomenal new opportunity, we are looking for an enthusiastic and driven colleague who can take up this challenging role as QA Associate. The responsibilities & the impact YOU will have:

    • Ensure that in a timely manner a clear and quality prospected advice is given to all cGMP and/or quality related issues encountered during (non)routine operations. Lead all aspects of site investigations and ensure that all CAPAs are implemented and effective within agreed timelines.
    • Assist in the preparations for and during inspections (FDA, EMA etc.) to accomplish a successful audit.
    • Perform level assessment, review and approval of (deviation related) change controls.
    • Partner with site colleagues to ensure all site changes and projects are conducted in a compliance to cGMP and company quality requirements.
    • Assess, review and approve study protocols and reports to assure that studies will be executed in a controlled and systematic manner conform cGMP and regulatory requirements e.g. but not limited to stability, validation, analytical technical transfer
    • Act as member in Quality Risk Management and /or root cause investigation sessions.

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    What are Johnson & Johnson perks and benefits

    Child care benefits

    Paid maternity

    Unpaid maternity

    Paid paternity

    Unpaid paternity

    Paid adoptive

    Short term disability

    About the company

    Industry: Consumer Packaged Goods: Packaged Products
    By caring for the world one person at a time, we aspire to help billions of people live longer, healthier, happier lives. This aspiration inspires and unites the approximately 127,100 employees of Johnson & Johnson across more than 250 operating companies in 60 countries. We embrace research and science, bringing innovative ideas, products and services to advance the health and well-being of people. For 130 years, the Johnson & Johnson Family of Companies has been committed to caring for people around the world.

    Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020

  • 4.2/5 in overall job satisfaction

  • 4.3/5 in supportive management

  • 72% say women are treated fairly and equally to men

  • 88% would recommend this company to other women

  • 85% say the CEO supports gender diversity

  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).

  • Global exercise reimbursement.

  • Two weeks off (one of them fully paid) for volunteer work.