Quality Control Analyst II

Job Description
About the role:

As a Quality Control Analyst II
, you will play a critical role in ensuring the safety, quality, and compliance of Takeda's life-changing therapies. In this role, you'll perform analytical testing, evaluate laboratory data, support quality systems, and help ensure manufacturing operations meet GMP, GLP, and regulatory requirements.

Working in a collaborative Quality Control environment, you'll utilize laboratory instrumentation, troubleshoot technical issues, support investigations, and partner with Manufacturing, Quality Assurance, Engineering, and other cross-functional teams to maintain operational excellence. Depending on business needs, this role may support QC Analytical, Microbiology, Compliance, QCMIS, or Laboratory Operations
, providing opportunities to develop expertise across multiple Quality functions. Your work will directly contribute to delivering safe, high-quality therapies to patients around the world.

• Perform analytical testing using established laboratory methods and techniques, including High-Performance Liquid Chromatography (HPLC) and other analytical instrumentation, while ensuring accurate, timely, and compliant results.

• Analyze laboratory data, prepare technical documentation and reports, and maintain accurate records using Laboratory Information Management Systems (LIMS) and other laboratory software.

• Troubleshoot laboratory equipment, analytical methods, and testing issues, escalating complex problems when appropriate and supporting timely resolution.

• Support laboratory investigations, auditing activities, Corrective and Preventive Actions (CAPAs), and continuous improvement initiatives to strengthen quality and compliance.

• Maintain laboratory equipment, perform routine maintenance activities, and ensure instrumentation remains qualified and operational.

• Adhere to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), safety requirements, and applicable regulatory guidelines while promoting a culture of quality and compliance.

• Collaborate with Manufacturing, Quality Assurance, Engineering, and other cross-functional partners to communicate testing status, resolve issues, and support production timelines.

• Assist with method implementation, laboratory documentation, and quality control processes while supporting operational excellence across laboratory functions.

• Participate in training activities, share technical knowledge with team members, and support additional laboratory responsibilities as assigned.

• Typically requires a Bachelor's degree in Chemistry, Biology, Biochemistry, Microbiology, Engineering, or another related scientific discipline

• Minimum of 3+ years of laboratory, quality control, or analytical testing experience in a pharmaceutical, biotechnology, medical device, or other regulated manufacturing environment required.

• Experience performing analytical testing using wet chemistry, biochemical methods, High-Performance Liquid Chromatography (HPLC), and other laboratory instrumentation required.

• Working knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), laboratory safety requirements, and applicable regulatory standards required.

• Experience using Laboratory Information Management Systems (LIMS) or similar laboratory software, with proficiency in laboratory documentation, data analysis, technical report writing, and interpretation of analytical results required.

• Strong technical troubleshooting, analytical problem-solving, and organizational skills, with the ability to manage multiple priorities while maintaining accuracy, compliance, and attention to detail required.

• Experience operating, maintaining, and troubleshooting laboratory instrumentation and equipment, including analytical equipment, incubators, autoclaves, or similar laboratory systems required.

• Excellent verbal and written communication skills, with the ability to collaborate effectively across Manufacturing, Quality Assurance, Engineering, and other cross-functional teams required.

• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint required.

• Experience…