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Job Description

About the role:

This position is responsible for providing Quality Assurance support and oversight for the QC organization. In providing QA oversight for QC, this position will specifically review/approve lab investigations, deviations, SOPs, Analytical Method Validation protocols and reports. This position will identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Takeda Quality practices.

This position will also be responsible for performing GEMBA’s in QC and provide necessary support. The incumbent will be responsible for handling multiple tasks and demonstrate effectiveness in task completion, decision-making and training investigation writers.

How you will contribute:

• Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude through collaboration with laboratory supervisors or other involved departments.

• Leads ongoing, daily departmental Quality Assurance support for QC and attend QC meeting to assess the situations and workload.

• Active participant in lab investigations through each step of the process (providing guidance as needed)

• Provide Quality Assurance support and oversight for QC organization. Review and approve documents such as Deviations, SOP’s, LIR’s, OOL’s, OOR, Protocols etc. authored by QC organization.

• Review and approve Analytical Method Validation/Transfer Protocols and Reports

• Participate in problem solving sessions and in rDMAIC’s as needed.

• Attend/participate in daily QC Tier meetings

• Support internal and external laboratory audit readiness efforts.  

• Provide training and coaching to local employees and others as needed on relevant area(s).

What you bring to Takeda:

Typically requires bachelor’s degree in science, engineering, or other related technical field.  3+ years of related experience.  Bachelors’ Degree in Chemistry or Biological Science is preferred.  Must have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

• Knowledgeable of laboratory tests / equipment including the use of statistical method (previous experience in GMP QC lab is a plus)

• Strong problem-solving and analytical skills are required.

• Ability to handle multiple tasks concurrently and in a timely fashion.

• Must have good organizational, verbal and written communication skills; able to efficiently communicate with cross-functional teams and management on recommended course of action, with minimal assistance.

• Self-driven individual that requires minimal supervision

• Knowledge of basic chemical and biological safety procedures.

• Understanding of manufacturing and facility processes.

• Demonstrate technical writing skills (e.g. investigation reports) and the ability to seek and identify solutions.

• Demonstrate effectiveness in supporting continuous improvement and promoting the control and prevention of potential issues.

• Good computer skills, knowledge of Microsoft Word, Excel, and PowerPoint.

• Work with minimal supervision.

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 th