QA Document Control Specialist
qiagen · Wroclaw ·
- Work mode
- Hybrid
- Category
- QA
Overview
At QIAGEN, we are driven by a simple but powerful vision: making improvements in life possible.
We’re dedicated to revolutionizing science and healthcare for the better. From our entrepreneurial roots to our current global presence, we've grown into a force for positive change. With thousands of employees across six continents, collaboration is our greatest strength. We’re always striving to identify talented individuals to join our exceptional teams.
We have played a pivotal role in shaping modern science and healthcare, and we're just getting started. If you're someone who thrives on new challenges, values diversity and wants to make a tangible difference in people's lives, then QIAGEN is the place for you.
At QIAGEN, every day is an opportunity to make a real-life impact.
Join us, grow with us, and together, let's shape the future of biological discovery.
About the opportunity
As a QA Document Control Specialist, you will help ensure the accuracy, integrity, and compliance of quality documentation within QIAGEN's Quality Management System. This role offers the opportunity to work independently while collaborating with stakeholders across different functions and locations.
Your tasks include
- Reviewing operational documentation for completeness, consistency, and compliance with QIAGEN procedures and applicable quality standards, including ISO 9001, ISO 13485, QSR 820, 21 CFR 820, and 21 CFR Part 11.
- Administering documents, user accounts, access rights, and document-related training within the electronic Document Management System (eDMS).
- Editing documents, assigning reference numbers, and maintaining the document register in accordance with established requirements.
- Supporting eDMS users with technical and process-related questions and handling system requests submitted through ServiceNow.
- Generating, processing, monitoring, and reporting system data related to documents, users, and training.
- Maintaining eDMS configurations and supporting the testing and validation of new system versions and patches.
- Preparing procedures, work instructions, training materials, and e-learning content, as well as delivering training to eDMS users.
- Sharing knowledge within the team and coordinating the onboarding and training of new team members.
- Participating in efficiency and process-improvement projects, including implementing more complex changes with support from the Team Leader.
- Supporting internal and customer audits in the areas of document control and related training.
- Collaborating effectively with internal customers, other departments, and business partners.
Your profile
- Experience or a strong interest in Quality Assurance, document control, quality systems, or regulated operational processes.
- Understanding of document compliance principles and quality standards, preferably ISO 9001, ISO 13485, QSR 820, 21 CFR 820, or 21 CFR Part 11
- Strong attention to detail and the ability to verify the completeness, consistency, and formal correctness of documentation.
- Good analytical and problem-solving skills, particularly when supporting users with system or process-related issues.
- Ability to prepare clear procedures, work instructions, reports, and training materials.
- Strong communication and collaboration skills, with a willingness to share knowledge and deliver training.
- A proactive approach to continuous improvement and readiness to participate in cross-functional projects.
- A service-oriented mindset and the ability to maintain positive relationships with internal and external stakeholders.
What we offer
Private medical care
Group Life Insurance
Multisport card
Flexible benefits platform
Language classes
Pension Scheme (PPE) after 12 months
Childcare subsidy
Training and development programs
Happy Monday (snacks provided)
Attractive location (Sky Tower)
Hybrid work (conditional to your role)
Our people are the heartbeat of everything we do. Passion drives us as we push boundaries to innovate and evolve. We inspire with our leadership and make an impact with our actions. We cultivate a collaborative, supportive environment where each individual and team can flourish. We champion accountability and encourage entrepreneurial thinking.
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.
Please make sure to send an English version of your CV!