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Quality Auditor

Company: Avantor, Inc.
Location: Allentown
Posted on: March 24, 2020

Job Description:

Job SummaryThe Global Supplier Quality Auditor will support the global supplier auditing process across all Avantor sites. He/she will coordinate and conduct supplier audits to ensure compliance with company procedures and the quality standards to which the product(s) are purchased. The Quality Auditor will address auditing for all suppliers of FDA regulated products (Excipient, API, Medical Device, Food grade), contract testing laboratories and primary packaging suppliers using company procedures and regulations and/or industry guidance documents. He/she will help the company maintain FDA compliance by lowering our risk on regulated items and confirming high quality of new suppliers.MAJOR JOB DUTIES AND RESPONSIBILITIES (Listed in order of importance)

  • Leads and performs on-site quality system audits of Suppliers in accordance with Avantor procedures and FDA regulations (and/or international guidances) and prepares associated and required report documentation
  • Assists in writing and updating Policies, Procedures, WI and Forms for the Global Supplier Management Lifecycle
  • Initiates, evaluates, and completes internal Management of Change, (MOC) resulting from supplier changes
  • Accountable for supplier risk evaluation within Avantor new product setup process
  • Point of Contact for customer audits of Avantor manufacturing sites, specifically to address Supplier Management topics
  • Coordinates with customers for release of audit Executive Summaries
  • Works closely with the Compliance Team to identify best practices for deploying the Supplier Management Lifecycle to all locations globallyQUALIFICATIONS (Education/Training, Experience and Certifications)
    • Bachelor of Science degree in chemistry, biology, natural science or related field is required. An emphasis on quality or chemical discipline is preferred
    • Minimum of ten (10) years of experience in Quality Assurance in a GMP manufacturing/packaging/testing environment
    • ASQ Certified Quality Auditor (CQA) certification (or equivalent) preferred
    • Experience as a Quality Auditor either internal or supplier for ISO 9001:2015, 14001, 13485, IPEC, USP General Chapter , ICH Q7, ICH Q9
    • Comprehensive understanding of FDA regulations for food, pharma and medical devices, ICH Guidelines, IPEC, USP/NF, European Directives and other cGMP requirements
    • Strong familiarity with and understanding of regulatory and quality assurance procedures, systems, and operations
    • Experience with SAP highly preferred KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)
      • Detail oriented
      • Strong sense of urgency, initiative, drive
      • Demonstrated strong interpersonal skills
      • Ability to meet tight deadlines
      • Demonstrated ability to multi-task
      • Excellent listening and communication skills
      • Ability to interpret an extensive variety of information in written, verbal and diagram formats
      • High level of professionalism and good judgment
      • Strong organizational and prioritization skills
      • Ability to deal effectively with people in all situations and at all levels and differing cultures.
      • Strong project management skills and ability to work independently and effectively manages time
      • Ability to read, analyze, and interpret common and technical journals, financial reports, and legal documents. Familiarity with chemical nomenclature and manufacturing terminology, required
      • Ability to learn and navigate multiple software systems readily ORGANIZATIONAL RELATIONSHIPS/SCOPE: The Global Supplier Quality Auditor will report directly to the Global Director, Supplier Quality and interact with the Global Compliance team on a regular basis. He/she will interact with both internal and external contacts at all levels of the organization including Global Procurement, Marketing, suppliers and external customers. WORKING CONDITIONS: The work environment is an office setting. The duties of the job will require the Global Supplier Quality Auditor to travel approximately 75% of the time, both domestically and internationally. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. DISCLAIMER:The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.Avantor is proud to be an equal opportunity employer.EEO StatementWe are an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.For more information about our commitment to equal employment opportunity, please Privacy Policy(Links to (1) EEO is the Law poster and any supplements, (2) pay transparency nondiscrimination statement, and (3) if desired, Company EEO/AA StatementAvantor is a leading global provider of integrated, tailored solutions for the life sciences and advanced technology industries. Strengthened by the recent acquisition of VWR, the Company is a trusted partner to customers and suppliers from discovery to delivery. With operations in more than 30 countries and a diverse portfolio that includes more than four million products, Avantor enables customer success through innovation, cGMP manufacturing and comprehensive service offerings. Collectively, we set science in motion to create a better world.Learn more at

Keywords: Avantor, Inc., Allentown , Quality Auditor, Accounting, Auditing , Allentown, Pennsylvania

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