Quality Control Scientist
QIAGEN | |
United States, Massachusetts, Beverly | |
Jan 30, 2025 | |
Overview
At the heart of QIAGEN's business is a vision to make improvements in life possible. Position Description We are seeking a highly motivated and detail-oriented Scientist to join our Quality Control (QC) Operations Support team. The successful candidate will play a critical role in the validation, implementation, and optimization of QC processes, as well as contribute to development and transfer of analytical methods and technologies. This role involves cross-functional collaboration and ensures the QC processes align with regulatory requirements, company standards, and project timelines. Primary Responsibilities - Plan, design, and execute validation activities for QC processes in accordance with regulatory guidelines - Develop and document validation protocols and reports for equipment, analytical methods and QC workflows - Perform risk assessments to identify critical process parameters for QC process - Implement new QC processes and analytical methods for new product launch and technology transfer, ensuring seamless integration into existing workflows - Identify opportunities for optimization of QC processes to improve efficiency, accuracy, and compliance - Conduct troubleshooting and root cause analysis for QC-related issues - Author, review, and update SOPs to reflect current practices and ensure alignment with regulatory requirements - Train QC personnel on newly developed or revised SOPs and ensure adherence to procedures - Lead and support the transfer of analytical methods and QC processes from R&D or external partners to QC, establish transfer protocols, define acceptance criteria and document results - Collaborate with cross-function teams, such as regulatory affairs, to ensure successful method and process transfers - Analyze QC data to identify trends, variances, and areas for improvement - Generate comprehensive technical reports and summaries for internal and external stakeholders Position Requirements - Ph.D. or Master's degree in Molecular Biology, Biochemistry, Microbiology, biotechnology, or a related field. Equivalent experience may be considered. - Ph.D. with 2+ years or Master's with 4+ years of experience in QC or related roles with the biotech or life sciences industry. Hands-on experience in analytic method validation, QC process optimization and tech transfer. - In depth knowledge and technical proficiency in molecular biology, nucleic acid biochemistry, gene expression profiling and target amplification. Familiar with PCR, qPCR, RT-PCR, radioactive assay, nuclease characterization etc.; experience in Next Generation Sequencing is highly desirable. - The position requires work with potentially biohazardous and/or chemically hazardous materials and the ability to lift and carry 25lbs. Personal Requirements - Strong analytical and troubleshooting skill. - Strong communication skills; oral and written. - Strong collaboration and teamwork skills. - Capable of self-learning and continuous learning for the QIAGEN processes, products and technical platforms. - Capable of working independently with minimal supervision. - Ability to use general lab equipment. Proficient in MS office applications. - The work environment is fast-paced and involves the ability to quickly change priorities and multi-task while maintaining a professional demeanor. What we offer At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN. QIAGEN complies with applicable laws regarding the confidentiality of employee health information and the reasonable accommodation of individuals with disabilities and/or sincerely held religious beliefs. Candidates who require accommodation should contact Benefits@QIAGEN.com. This policy is part of QIAGEN's ongoing efforts to support public health efforts and to ensure the safety and-well-being of its employees, customers, business partners, and community. |