Senior Operations Specialist

QIAGEN•Frederick, CO

100d•$68,000 - $80,000•Hybrid

About The Position

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 In this role, you contribute directly to the production of Next Generation Sequencing (NGS) diagnostic kits and Molecular Diagnostics products within a GMP‑compliant manufacturing environment at QIAGEN. You ensure that manufacturing activities meet applicable regulatory requirements while driving process robustness, operational excellence, and continuous improvement. Working cross‑functionally, you support technology transfers, troubleshoot complex manufacturing issues, and help maintain a high‑performing laboratory environment that enables reliable, high‑quality diagnostic solutions.

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).
Ability 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.

Nice To Haves

Lean and SAP knowledge is an advantage.

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.