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
At QIAGEN, you will play a critical role in ensuring that our products meet the highest quality standards before reaching customers or progressing through the manufacturing process. As a QA Specialist II, Product Release, you will be responsible for reviewing and auditing quality documentation, supporting product disposition activities, and helping maintain compliance with applicable regulatory requirements and quality standards. This role requires a detail-oriented professional who thrives in a regulated environment, enjoys collaborating across functions, and is passionate about continuous improvement and product quality.
This role is 25 hours per week, Monday-Friday. This is a 3-month contract.
Your tasks include
- Review and audit device history records, batch records, and other quality documentation to ensure compliance with internal procedures, cGMP requirements, ISO standards, FDA regulations, and other applicable quality requirements.
- Perform product release activities and disposition decisions for materials and finished goods approved for manufacturing use or customer distribution.
- Support the control of products throughout their lifecycle, including review of deviations, nonconformities, and related quality records.
- Partner with Operations and cross-functional teams to resolve documentation issues and ensure compliance with quality requirements.
- Contribute to continuous improvement initiatives by identifying opportunities to enhance Product Release processes, procedures, and efficiency.
- Participate in departmental metric collection, analysis, and reporting to support quality objectives and operational excellence.
- Serve as a quality resource for training, cross-functional collaboration, and quality-related inquiries across the organization.
Your profile
- Bachelor's degree in a scientific discipline or equivalent scientific experience, with a minimum of 2 years of professional experience, preferably within a regulated industry.
- Working knowledge of cGMP, Quality System Regulations (QSRs), ISO standards, and other applicable regulatory requirements.
- Strong attention to detail and auditing skills, with the ability to accurately review complex documentation and data.
- Demonstrated ability to manage multiple priorities, work independently, and remain flexible in a fast-paced manufacturing environment.
- Effective communication and interpersonal skills, with the ability to collaborate and build relationships across all organizational levels.
- Proficiency with Microsoft Office applications; experience with ERP systems and/or Electronic Document Management Systems (EDMS) is advantageous.
- Team-oriented mindset with strong organizational skills and the ability to support demanding projects while maintaining quality and compliance standards.
The typical pay rate for this role is $30-$35/hour . This temporary and/or contract position is not eligible for QIAGEN’s company benefits. The position includes only those benefits mandated by applicable state and federal law, if any, which are provided by the agency employer.
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.