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
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
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.
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
The QA Specialist, Labeling, will be a liaison between multiple
internal departments, as well as external Suppliers.
- 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
- Create, manage and revise Product Labeling electronic files
based on approved requests, in accordance with the Change Control
- Ensure accurate transfer of Product Labeling electronic files
to approved suppliers.
- Review and approves Supplier label proofs, in support of
- 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
- BA/BS or equivalent experience required.
- Minimum of 2 years of Desktop Publishing experience
- 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
- 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.