AnnArborRecruiter Since 2001
the smart solution for Ann Arbor jobs

Quality Assurance Specialist - Labeling

Company: Qiagen N.V
Location: Ann Arbor
Posted on: May 3, 2021

Job Description:


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 and international, 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

The Quality Assurance Specialist - Labeling, will be responsible for creating, revising and managing product labels utilizing Desktop Publishing, for all NeuMoDx product labels.

He/she will be responsible for ensuring compliance of labels based on NeuMoDx Regulatory requirements, per FDA regulations and ISO standards.

The QA Specialist, Labeling, will be a liaison between multiple internal departments, as well as external Suppliers.

Position Requirements

  • Provide core support for Product Labeling electronic files used to create NeuMoDx product labeling, with input from Regulatory Affairs, and in compliance with FDA regulations and ISO standards.
  • Create, manage and revise Product Labeling electronic files based on approved requests, in accordance with the Change Control system.
  • Ensure accurate transfer of Product Labeling electronic files to approved suppliers.
  • Review and approves Supplier label proofs, in support of production orders.
  • Work collaboratively with Quality Assurance, Regulatory Affairs, Purchasing, Production and approved external Suppliers to manage project timelines and assist in resolving issues.
  • Responsible for managing and controlling labeling files for Production release and use.
  • Assist with labeling process improvements, including writing related procedures/instructions.

Personal Requirements

  • BA/BS or equivalent experience required.
  • Minimum of 2 years of Desktop Publishing experience required.
  • Minimum 2 years of experience in an ISO 13485 and/or FDA 21 CFR 820 (medical device) regulated industry.
  • Must be detail-oriented, with the ability to organize and manage multiple tasks and projects.
  • Strong written and verbal communication skills, with ability to work with multiple teams collaboratively.
  • Must be able to organize and manage multiple tasks and projects.
  • Experience with label printing and equipment preferable.

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, religion, sex (including pregnancy, childbirth, and medical conditions related to pregnancy, childbirth, or breastfeeding), sex stereotyping (including but not limited to assumptions about a person's appearance or behavior, gender roles, gender expression, or gender identity), gender, gender identity, gender expression, national origin, age, mental or physical disability, ancestry, medical condition, marital status, military or veteran status, citizenship status, sexual orientation, genetic information, or any other status protected by applicable law.

Keywords: Qiagen N.V, Ann Arbor , Quality Assurance Specialist - Labeling, Other , Ann Arbor, Michigan

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Log In or Create An Account

Get the latest Michigan jobs by following @recnetMI on Twitter!

Ann Arbor RSS job feeds