Senior Operations Specialist

About the role

Contribute directly to the production of Next Generation Sequencing (NGS) diagnostic kits and Molecular Diagnostics products within a GMP-compliant manufacturing environment at QIAGEN.

Ensure that manufacturing activities meet applicable regulatory requirements while driving process robustness, operational excellence, and continuous improvement.

Work cross-functionally, support technology transfers, troubleshoot complex manufacturing issues, and help maintain a high-performing laboratory environment that enables reliable, high-quality diagnostic solutions.

Responsibilities

• Prepare buffers, oligonucleotide libraries, enzyme mixes, and complete kit components for NGS products according to production schedules, ensuring accurate and compliant batch record documentation.
• Execute, review, and accurately complete batch records and all production-related documentation in line with GMP and quality requirements.
• Maintain laboratories and ensure proper operation, monitoring, and maintenance of lab environments and instrumentation.
• Initiate and support investigations related to product, process, or equipment nonconformities.
• Support new product introductions and technology transfers from development to manufacturing and between sites, with a focus on quality, supply continuity, and cost efficiency.
• Contribute to validations and drive process improvements, including cost-reduction and efficiency initiatives.
• Build and manage effective relationships with internal and external stakeholders while supporting departmental and corporate goals.

Requirements

• Bachelor’s degree in a scientific or engineering discipline with 6 years of relevant manufacturing operations experience, or a Master’s degree with 2–4 years of relevant experience.
• Proven experience in a GMP/ISO-regulated biotechnology or diagnostics manufacturing environment.
• Hands-on expertise with magnetic beads, oligonucleotide quantification, and NGS library preparation.
• Solid understanding of applicable regulations such as QSR, ISO, OSHA, IVDD, and MDD.
• Strong analytical and mathematical skills, including confident handling of metric volumes and measures.
• Proficiency with general laboratory equipment and intermediate to advanced Microsoft Office skills (Word, Excel, Access, PowerPoint); Lean and SAP knowledge is an advantage.
• Able to work in a fast-paced environment, manage changing priorities, troubleshoot complex issues, and safely handle potentially biohazardous or chemically hazardous materials, including lifting up to 25 lbs and sitting for extended periods.

Qualifications

• Passion for innovation and a commitment to making a tangible difference in people's lives.
• Ability to thrive in a dynamic, collaborative, and supportive environment.
• Entrepreneurial mindset and a willingness to take initiative.

Skills

• Strong analytical and problem-solving skills.
• Effective communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Knowledge of regulatory compliance and GMP standards.

Benefits

What We Offer:

• Bonus/Commission
• Local benefits
• Referral Program
• Volunteer Day
• Internal Academy (QIALearn)
• Employee Assistance Program
• Hybrid work (conditional to your role)

Pay

The estimated base salary range for this position is $68,000-$80,000. Compensation will be based on the candidate’s experience, skills, geographic location, and other job-related factors.