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Job Description

About the role:

As a Quality Control Analyst II for QC Compliance is to provide technical expertise and support for the Operational Support functions of the QC Laboratory through ownership and participation in Quality Record management activities.

How you will contribute:

• Author and revise GMP documents and Quality Control records (e.g. Test Methods, SOPs, change controls, etc.)
• Train staff in general Quality Control activities and updates
• Train staff in Deviation and Laboratory Investigation processes and techniques
• Collaborate in the mitigation of any environmental, Health, and Safety (EHS) needs and risks
• Identify and implement improvement initiatives to improve yield, reliability, and/or process robustness. This may require leading and implementing change controls.
• Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to the biopharmaceutical industry, as well as technical understanding/problem solving capability.
• Responsible for organizing data and preparing appropriate documentation, including presentation materials, for assigned projects.
• Lead any CAPA investigations
• Lead problem solving and root-cause analysis sessions
• Perform GEMBA and other information gathering techniques to support investigation completion and laboratory continuous improvement
• Interact with Quality, Manufacturing, Engineering and Tech Service units
• Manage complex investigations using DMAIC tools
• Ensure effective implementation of corrective and preventive actions
• All other duties as assigned by Leadership

What you bring to Takeda:

• Requires bachelor's degree in science, engineering, or other related technical field. 2-5 years of related experience in pharmaceutical or similar regulated industry.
• Experience with laboratory investigations in the GMP pharmaceutical industry preferred
• Must know quality laboratory operations and government regulations pertaining to pharmaceutical and medical device manufacturing labs.
• Must have the ability to manage multiple tasks and responsibilities for the QC Lab.
• Must have the ability to manage complex investigations
• Must possess excellent technical and interpersonal skills and be able to communicate with all level personnel and regulatory authorities.
• Advanced knowledge in cGMP standards, preferred.
• Strong problem-solving and analytical skills are required.
• Possess knowledge of core Quality Control principles and support systems.
• Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross-functional teams and management on recommended courses of action, with minimal assistance.
• Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
• Self-driven individual that requires minimal supervision.
• Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint).

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Prolonged periods sitting at a desk and working on a computer.
• Frequently or constantly to lift, carry push, pull, or move objects and repetitive motions.
• Work is performe