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 6000 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

Position Summary:
The Specialist QA, is primarily responsible for the creation, content and changes of labeling outputs. The position will represent quality assurance and act as an interface between all departments involved in product and production label changes. The QA Specialist is responsible for assessing change needs, impacts, and partner management activities, as well as supporting organizational change activities. As such, the role interacts regularly with other departments, functional peers, and personnel at all levels within the organization.

Key responsibilities include, but are not limited to:

• Core support for Change Control, and Labeling Systems QA team in support of FDA regulations and ISO and other international standards.
• Support process changes arising from updates to labeling, materials or finished goods requirements.
• Act as labeling change control champion by being responsible for the change control of labeling activities from Initiation through completion.
• Participate in change control meetings.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• First-tier resource for change teams on issues related to labeling change quality assurance (QA).
• Work on Change Control-related projects of diverse scope, in an independent or semi-independent manner.

Position Requirements

Position Requirements

• BA/BS, in scientific or engineering discipline, preferrable Life Science, IVD or Medical Device discipline or equivalent experience required.
• A minimum of 2 years of experience in an ISO 13485 and/or FDA 21 CFR 820 (medical device) regulated industry preferred, but not required.
• Ability to train inter-disciplinary teams in quality processes, procedures, and adherence
• Demonstrated experience working with cross-functional groups (R&D, Operations, Clin/Reg, etc.) requiring strong inter-personal skills, excellent communication skills, and the ability to work well under pressure
• Working knowledge of computer systems and databases desired
• Must be able to communicate complex situations effectively with employees at all levels of the organization in writing, on the telephone and in person.
• Be able to effectively monitor and manage multiple projects and timelines
• Demonstrated experience supporting change controls

• Excellent computer skills, including MS Office, Adobe. Familiarity with Sharepoint, SAP desirable.

Personal Requirements

Personal Requirements

• Must be detail-oriented with strong written and verbal communication skills.
• Excellent organizational and planning skills.
• Team player with a customer-oriented way of working.

QIAGEN requires proof of full COVID-19 vaccination as a condition of employment for new hires in all U.S. states other than Montana effective as of September 1, 2021. New hires and candidates will be required to present proof of full COVID-19 vaccination within three business days of start date or upon entry into the office (i.e., for interviews), whichever comes first. QIAGEN complies with applicable laws regarding the confidentiality of employee health information and the reasonable accommodation of individuals with disabilities and/or sincerely held religious beliefs. Candidates who require accommodation should contact Benefits@QIAGEN.com. This policy is part of QIAGEN’s ongoing efforts to support public health efforts and to ensure the safety and-well-being of its employees, customers, business partners, and community.

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.

Job Type: Full-time

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