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Job Description

About the role:

As a Supervisor, Quality Control, you will have a staff performing many biological, chemical, or physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods and may include environmental monitoring programs. You may be applicable to QC Analytical or Microbiological testing, Compliance, QCMIS, or Laboratory Operations. You will be responsible for results regarding product quality and conformance to regulations and quality policies. In some instances, you will be responsible for a functional area and may not have subordinates.

How you will contribute:

• Plans and schedules the work of QA analysts, QA technicians and inspectors.
• Ensure that all document control activities, inspection, and test procedures are completed and documented.
• Review all quality assessment results and determine whether to accept or reject manufactured products during the inspection process.
• Coordinate the release of licensed products, intermediate and clinical/IND lots, and Packaging, according to schedule.
• Track performance indicators such as average number of defects per million units inspected as a process average for all products and document control and retention schedule adherence.
• Work with Production Management, Quality, and Engineering to ensure adequacy and appropriateness of inspection parameters, product specifications, test methods, and other controlled documentation.
• Evaluate new raw materials to develop first of code criteria for raw material testing.
• Prepare daily reports and monthly summary on department specific performance indicators.
• Maintain inspection documentation procedures, QA inspection instructions and department policy procedures. Ensure product compliance regulations are followed.
• Hire, trains and evaluates all personnel.
• Navigate, answer alerts and review Batch Records in EBM.
• Provide necessary floor support to the manufacturing teams and help in resolving compliance concerns.
• Responsible for change control activities/documentation. Required to perform review of submission documents applicable to the product of the department.
• Coordinate quarterly review meetings of quality data and trends to upper management.
• Coordinate customer complaint response and tracking.
• Working knowledge of statistics and production processes.
• Must have AS400 or PC knowledge.
• Identify when proper practices/ procedures are not performed.
• Follow SOPs and identify processes and results.
• Implement changes and corrections.
• Escalate accordingly.
• Ensure communication of issues.
• Ensure communication between personnel, groups, and between departments.
• Coordinate activities, schedules staff.

What you bring to Takeda:

• Requires Bachelor's degree in science, engineering or other related technical field. 5+ years of related experience.

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:

• In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility.
• May work in a confined area.
• Inside working conditions.
• Some clean room and cool/hot storage conditions.
• May work in a controlled environment requiring special gowning and wear protective clothing over the