Contract Quality Assurance Specialist
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 thrive on new challenges, value diversity, and want to make a tangible difference in people's lives, QIAGEN is the place for you. Every day is an opportunity to make a real‑life impact.
About the role
As a QA Specialist II, Product Release, you will ensure that our products meet the highest quality standards before reaching customers or progressing through manufacturing. You will review and audit quality documentation, support product disposition activities, and help maintain compliance with regulatory requirements and quality standards. The role is detail‑oriented, operates in a regulated environment, and collaborates across functions while driving continuous improvement.
Responsibilities
- Review and audit device history records, batch records, and other quality documentation to ensure compliance with internal procedures, cGMP, 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 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.
Requirements
- Bachelor’s degree in a scientific discipline or equivalent scientific experience.
- 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; 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; 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.
Pay
The typical pay rate for this role is $30‑$35 per hour.
Schedule
25 hours per week, Monday‑Friday. This is a 3‑month contract position.
Benefits
- Bonus/Commission
- Local benefits
- Referral Program
- Volunteer Day
- Internal Academy (QIALearn)
- Employee Assistance Program
- Hybrid work (conditional to your role)