Quality Assurance Auditor II

Posted 3 Days Ago
Be an Early Applicant
Assen, NLD
In-Office
Entry level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
As a Quality Assurance Auditor, you will conduct audits on bioanalytical studies and ensure compliance with regulations. Responsibilities include planning, reporting, interpreting guidelines, and facilitating audits and inspections.
Summary Generated by Built In
Quality Assurance Auditor II

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

The Early Development Services (EDS) division of ICON is a global leader in providing early-phase clinical research (phase I and IIa) and bioanalytical services to the pharmaceutical and biotechnology industries. With a reputation built on excellence, quality and professionalism, we work with leading pharmaceutical and biotechnology companies, performing clinical research and bioanalytical trials on many of the most advanced experimental drugs and biologics in development today. Employees of EDS are enthusiastic and dedicated and work in a dynamic informal organization.

This is an onsite/office-based role within the ICON premises in Assen, Netherlands.

What will you be doing as Quality Assurance Auditor?

We are looking for you to join our team in Assen, the Netherlands where you will take responsibility for Bioanalytical Laboratory study audits and parts of the ICON audit program.

  • Perform routine and complex study, vendor and process audits according to GxP regulations, scientific guidelines, client expectations and/or ICON SOPs. May function as a lead auditor on an (international) audit team. Ensure planning, conduct, reporting, responses and FU actions are managed according to internal procedures.

  • Further aspects of this challenging role include the interpretation of regulations and guidance documents governing Bioanalytical studies (GLP, GCP, EMA etc) and applying this within day-to-day structures for ICON staff and client representatives.

  • You will be additionally responsible for facilitating client audits and regulatory inspections at ICON.

What do we ask of you?

  • Life science degree (Secondary vocational education (MBO), Bachelor or University Degree) from an accredited institution.

  • Previous experience working as a GLP Auditor is considered as an asset.

  • Additional experience on any of the following topics is considered a pro: Dataintegrity, CSV.

  • Work experience in a bioanalytical laboratory is considered an additional benefit.

  • Fluency in English.

  • You are a self-motivated, focused individual with excellent communication skills.

  • Commutable distance to Assen - you will be office based

#LI-JC3

#LI-Remote

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements

  • A range of health insurance offerings to suit you and your family’s needs.

  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.

  • Life assurance

  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply

Skills Required

  • Life science degree from an accredited institution
  • Previous experience working as a GLP Auditor
  • Experience in data integrity, CSV
  • Work experience in a bioanalytical laboratory
  • Fluency in English

ICON plc Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ICON plc and has not been reviewed or approved by ICON plc.

  • Healthcare Strength Benefits are described as comprehensive, with medical coverage and wellness initiatives highlighted. Larger sites are also associated with added wellness supports such as onsite fitness options and access to an employee assistance program.
  • Leave & Time Off Breadth Time-off and flexibility provisions are positioned as a meaningful part of the total package, including vacation/annual leave and flexible work scheduling. Flexibility is sometimes cited as helping offset long hours in certain roles.
  • Retirement Support Retirement and savings support is presented as a core component of the benefits package, including offerings such as pension arrangements in some locations and a U.S. 401(k) plan with company match. Financial planning resources are also emphasized as part of broader security benefits.

ICON plc Insights

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The Company
HQ: Dublin
34,685 Employees
Year Founded: 1990

What We Do

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

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