Senior QA Specialist
QIAGEN
Barcelona, Spain
hace 2 días

Overview

At the heart of QIAGEN’s business is a vision to make improvements in life possible.

We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.

Our most valuable asset are our employees more than 5000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.

There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.

If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic, international and diverse teams and want to make a real impact on people’s lives, then QIAGEN is where you need to be.

Join us. At QIAGEN, you make a difference every day.

Position Description

We are looking for a Senior QA Specialist to join STAT DX Life S.L., QA Operational Team in Barcelona.

STAT-Dx is focused on the development, manufacturing and commercialization of "Closer to Care" diagnostic solutions in areas where fast and accurate diagnostic results are crucial, such as infectious diseases and critical care.

QIAstat system is a versatile, easy-to-use platform that consolidates molecular and immunoassay techniques in a single device.

The QA Specialist is expected to operate and manage the document control system to meet Quality management requirements.

Position Requirements

  • Operate and manage the document control system to meet Quality Management requirements, review all changes to controlled documentation
  • Assuring conformance with the Quality System in accordance with 21 CFR Part 820 and ISO 13485.
  • Writes, reviews and maintains quality systems documentation
  • Management, storage and control of quality records
  • Creation and Maintenance of document templates
  • Ensuring regular meetings are organized and take meeting minutes
  • Supports the review of nonconformities or deviations, CAPAS in a regular basis and-participates of product release process in a daily basis
  • Support the supplier evaluation and manage the SCARs.
  • Communications with other departments and affiliates
  • Ensures Schedules are met and monitors compliance with manufacturing records

  • Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), local and state laws, health & safety guidelines, health authority regulations, and departmental processes.
  • Education

    Degree and / or post graduated qualification in Life Science or Engineering

    Experience

    At least 2-year experience working in a regular environment in healthcare, pharmaceutical or medical / IDV sector in QA / RA role desiderable.

    Personal Requirements

  • Fluent English essential
  • Good communication and organizational skills
  • Excellent PC skills in Word, Excel, PowerPoint
  • Good attention to detail
  • Ability to work cooperatively and effectively with others to establish and maintain good working relationships
  • Proven problem solving skills
  • Ability to use the initiative, be proactive, work with minimal supervision
  • Process / procedure driven person
  • What we offer

    At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement.

    We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams.

    We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.

    QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.

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