Quality Control Scientist

Responsibilities

• Perform molecular biology and biochemical assays involving DNA and RNA to support release, characterization, and stability testing of internally manufactured materials.
• Conduct core molecular biology techniques such as pipetting, PCR, qPCR, gel electrophoresis, and related sample preparation.
• Execute sequencing workflows and DNA/RNA sample preparation, including gDNA contamination analysis and endo‑and exonuclease assays.
• Prepare solutions and buffers accurately to support routine and specialized laboratory assays.
• Operate fragment analyzers and perform HPLC testing, utilizing Chromeleon software for data acquisition and analysis.
• Maintain method-specific inventory of reagents, consumables, and retention samples to ensure uninterrupted laboratory operations.
• Support subject matter experts and QC scientists by providing reliable assay execution, data, and documentation.
• Aid in daily laboratory setup, ensuring equipment, materials, and workspaces are ready for testing activities.
• Follow established SOPs and written procedures consistently to maintain assay integrity and regulatory compliance.
• Document all laboratory procedures carefully and accurately in accordance with GMP standards.
• Complete all required GMP documentation in compliance with applicable regulatory requirements.
• Contribute to a safe, organized, and efficient laboratory environment through proper handling of materials and adherence to quality practices.

Requirements

• Basic molecular biology laboratory skills, including accurate pipetting, PCR, gel electrophoresis, and related techniques.
• Hands-on experience with DNA and RNA sample preparation, sequencing, and qPCR.
• Proficiency in biochemical and molecular biology assays used for release, characterization, and stability testing.
• Demonstrated ability to follow written procedures and standard operating procedures precisely.
• Strong attention to detail and careful documentation of laboratory procedures in line with GMP standards.
• Experience with GMP documentation and working in a regulated laboratory environment.
• Experience managing and maintaining retention samples, reagent inventory, and method-specific consumables.
• Solid understanding of quality control principles in a laboratory setting.
• Educational background: Bachelor’s degree in Molecular Biology, Biochemistry, Biology, or a related scientific discipline.
• Experience: 1–3 years of hands-on laboratory experience in a QC, analytical, or regulated laboratory environment.
• Experience: 1–3 years of experience working under GMP conditions.
• Practical experience with DNA and RNA sequencing workflows and sample preparation.
• Familiarity with qPCR, gel electrophoresis, and other core molecular biology techniques.
• Experience operating fragment analyzers and performing HPLC testing, preferably with Chromeleon software.
• Ability to collaborate with scientists and technical experts in a multidisciplinary team.
• Strong written and verbal communication skills for clear documentation and reporting of results.

Qualifications

• Bachelor’s degree in Molecular Biology, Biochemistry, Biology, or a related scientific discipline.
• 1–3 years of hands-on laboratory experience in a QC, analytical, or regulated laboratory environment.
• 1–3 years of experience working under GMP conditions.
• Practical experience with DNA and RNA sequencing workflows and sample preparation.
• Familiarity with qPCR, gel electrophoresis, and other core molecular biology techniques.
• Experience operating fragment analyzers and performing HPLC testing, preferably with Chromeleon software.
• Ability to collaborate with scientists and technical experts in a multidisciplinary team.
• Strong written and verbal communication skills for clear documentation and reporting of results.