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Quality Auditor - Pharmaceutical/Medical Device

SQA Services·See all SQA Services jobs on Jobr

Posted about 2 months ago

OfficeTokyo390k - 390k USD
For nearly 30 years, SQA Services has been a leading provider of managed supplier quality services, offering audits, assessments, remote surveillance, corrective actions, remediation, inspections, and engineering solutions to manufacturers across all industries. We deliver these services by deploying a network of highly skilled associates based throughout the United States and in over 90 countries worldwide, ensuring rapid on-site support at your supplier locations. Our associates are expert quality assurance professionals with extensive experience and local expertise, enabling us to represent our clients on-demand and with greater speed and efficiency than our competitors.
 
We’re hiring a Pharma Quality Auditor. This is a contract opportunity in which you will perform supplier quality  audits at various suppliers in Japan. These audits are generally 1-2 days long. You are given the flexibility to accept or reject these assignments according to your own availability. 
### Key Responsibilities
  • Perform supplier audits at various sites within your region of residence
  • Assure quality in the supply chains of various clients within the pharmaceutical, medical device, cosmetics, biologics, and/or animal health industries
  • Coordinate, prepare, execute, and deliver supplier audits based on your own and the client schedule
  • Utilize your regulatory knowledge of various standards from ISO, CFR, FDA, etc…
  • Respond to the Content team in a timely manner regarding edits/questions to your audit report
  • Write audit reports in accordance with client specifications
    • ### Required Qualifications
  • 5+ years of hands-on audit experience in pharmaceutical, medical device, and/or biologics industries
  • Has been the lead auditor in at least 10 audits
  • Direct audit experience to 21 CFR part 210/211, EU Vol 4, and ISO 9001
  • Strong communication and writing skills
  • Proven ability to deescalate workplace conflicts effectively
  • Ability to adapt to new technology and software.
  • Willingness to travel regionally
    • ### Preferred Qualifications
  • Direct audit experience to ISO 17025, ISO 15378, IPEC GDP, ICH Q7 and/or ISO 13485
  • ISO certifications are a plus but not mandatory
    • Note: SQA is an Equal Opportunity Employer. Employment is based on merit and qualifications, and is not influenced by race, color, religion, gender, national origin, veteran status, disability, age, sexual orientation, gender identity, marital status, or any other legally protected status.​
     
    #ZR

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    Job details
    Workplace
    Office
    Location
    Tokyo
    Salary
    390k - 390k USD
    per year
    SQA Services logo
    SQA Services
    View company page

    SQA’s global network of quality experts represents the tip of the iceberg in terms of SQA’s capability, reliability, and accountability. Behind every carefully selected SQA Associate, there is a technical and administrative support team, a series of proven tools and processes, and a world-leading event management system providing unparalleled visibility and control.

    WebsiteLinkedIn+2
    Employees
    443
    Industry
    Business Consulting and Services
    Headquarters
    Palos Verdes Peninsula, California
    Founded
    1995
    Company location
    Palos Verdes Peninsula, California
    Specialties
    Supplier Quality Audits, Corrective Action Management, Quality Engineering, Quality Inspections, STEPQ Technology, Remediation, Validation, Risk Mitigation, and Part Approval Programs

    Key team members

    Veysel Zengin

    Veysel Zengin

    Rob Udo

    Rob Udo

    Cristina D'Antonio

    Cristina D'Antonio

    Orestes Velez Jr.

    Orestes Velez Jr.

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