Quality Control Development Scientist 1

QIAGEN•Germantown, TN

1d•$80,000 - $90,000•Hybrid

About The Position

The Quality Control Development Scientist I supports the development, optimization, transfer, and validation of QC test methods in a regulated diagnostics environment and drives continuous improvement across laboratory operations. Working with Quality Control, Manufacturing, and R&D teams, the role provides technical expertise, leads troubleshooting investigations, analyzes complex datasets, and helps ensure high product quality standards. The position independently manages scientific projects, mentors colleagues, and supports the transfer of technologies into routine Quality Control processes.

Requirements

Master's degree in Molecular Biology, Biochemistry, Biotechnology, Life Sciences, or a related scientific discipline.
At least 4 years of relevant industry experience.
Demonstrated technical expertise in molecular biology methods and Quality Control testing within a regulated environment.
Knowledge of test method development, transfer, validation, statistical analysis, and data interpretation.
Experience working in GMP-regulated environments.
Hands-on experience with advanced laboratory instrumentation such as HPLC, FTIR, ion exchange chromatography, or similar analytical technologies.
Proficiency with Microsoft Office applications and statistical software such as Minitab, JMP, or equivalent tools.
Strong communication, leadership, organizational, and problem-solving skills, with the ability to work independently and collaboratively in a fast-paced environment.

Nice To Haves

Experience in the diagnostics industry.
Familiarity with QSR, ISO, OSHA, IVD, and MDD regulations.

Responsibilities

Develop, optimize, and validate Quality Control test methods to support product quality, regulatory compliance, and laboratory efficiency.
Lead the transfer of products and test methods from acquisitions, R&D, or other QIAGEN sites into Quality Control operations.
Analyze, trend, interpret, and present data from routine QC testing, investigations, and validation activities.
Lead troubleshooting investigations involving manufacturing processes, Quality Control testing, and customer complaints through resolution.
Author, review, and maintain technical documentation, including SOPs, validation protocols, reports, and technical assessments.
Train, mentor, and provide technical leadership to Scientific Associates, Scientists, and Quality Control team members on laboratory methods and best practices.
Manage multiple projects, prioritize activities, and collaborate across functions to meet business objectives without compromising quality.