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Quality Associate II

4 weken geleden

Hoofddorp, Nederland Validated Cloud Voltijd

Who we are and what we do:

Validated Cloud is a leader in Cloud Hosting dedicated to servicing the Life Science community. The team at Validated Cloud owns, manages, and maintains a cloud infrastructure designed to meet the regulatory requirements in the US and EU. Validated Cloud enables compliant systems and provides an extremely high level of support for our customer's critical data.


Who we are looking for:

The ideal candidate is meticulous and uses industry guidelines to measure twice and cut once. You know and understand how critical all of the details are to ensuring compliance from Good Documentation Practices, Data Integrity, married with IT best practices and quality control. You appreciate the importance of paperwork and organization that comprises Quality Control coupled with team collaboration and occasional customer interaction.


A day in the life:

The Quality Associate will review and approve qualification documentation generated for the Validated Cloud environment. This includes executed protocols, scripts and change controls. This role will collaborate with functions across the company to investigate, resolve and document quality issues to ensure compliance with regulations and industry standards. The Quality Associate will participate in Quality Management System related initiatives to help improve processes and build efficiencies.

 

Duties and Responsibilities:

  • Work closely with Engineering and Product Management in reviewing and approving qualification documents
  • Ensure deviations, incidents and CAPAs are initiated, assessed and resolved appropriately in accordance with regulatory expectations
  • Assist in identifying and implementing improvements to policies and procedures
  • Ensure QMS documentation is filed and organized appropriately
  • Support internal, client and vendor audits as needed
  • Assist with internal reporting of KPIs
  • Support training initiatives


Required skills and qualifications:

  • Bachelor's degree in science/engineering
  • Works under minimal supervision
  • Attention to detail – some may call you a perfectionist
  • Highly motivated – driven to succeed and grow
  • Articulate written and oral communication – you know how to effectively deliver a message
  • Team and customer collaboration – you want your colleagues and customers to be happy and successful too
  • Microsoft Office 365/Windows proficient
  • 5+ years of experience in Quality
  • 3+ years of experience working in an FDA regulated environment, working hands-on with documentation and Quality Assurance – OR at least 3+ years of experience in a technology QA role
  • Experience writing, executing and reviewing test/validation plans under formal processes is a PLUS
  • Knowledge and understanding of ISO 9001 and/or ISO 27001 is a PLUS


What we have to offer:

A relaxed company culture which values work life balance. We work to live, value family and our time away from the office. Validated Cloud offers amazing benefits at no cost to you. Limitless potential to grow and learn valuable regulatory, validation, and quality control skills in one of the fastest growing industries.

Job Type: Full-time


Benefits:

  • Holiday pay 8%
  • Paid holidays
  • Bonus opportunities
  • Home office compensation (internet/phone)
  • Contribution towards personal pension scheme


Compensation package:

  • Bonus opportunities
  • Experience level: 5+ years


Schedule:

  • 8-hour CET shift
  • Monday to Friday


Work Location:

Hybrid (1-2 per week in the office)