Investigations Specialist

Role Summary

The Manufacturing Investigation Specialist is responsible for ensuring the quality of processes and product outputs. This role involves defining activities, processes, and standards to meet quality requirements, auditing and monitoring processes, and reporting deviations and defects. The role supports Takeda's mission by maintaining high standards in manufacturing and production.

Responsibilities

• Conduct deviation investigations with direct supervision
• Identifies root causes of manufacturing issues with minimal guidance
• Apply basic Corrective And Preventive Action principles under guidance
• Analyze manufacturing trends to identify patterns and suggest improvements
• Ensure adherence to regulatory and internal compliance during manufacturing processes
• Support process improvement initiatives based on analytical findings
• Provide entry-level technical support in resolving deviations
• Utilize data analysis skills to support decision-making processes
• Follows established Quality Assurance guidelines to maintain standards
• Performs basic auditing tasks under close supervision
• Communicates effectively within the team to facilitate information exchange
• Manages change control processes according to strict guidelines
• May require to work off-hours, extended periods of time occasionally
• Author and revise GMP documents and manufacturing records
• Work hours 8am to 5pm Monday through Friday

Qualifications

• Typically requires bachelor's degree in science, engineering or other related technical field. Some related experience preferred
• Professional (GMP industry) experience ideal

Skills

• Data analysis
• Quality assurance
• Root-cause analysis
• Deviations resolution
• Change control
• Documentation and GMP compliance

Education

• Bachelor's degree in science, engineering, or related technical field

Additional Requirements

• Work environment may require gowning and protective clothing
• Possible exposure to cold, wet environments and chemicals requiring protective measures
• Possible weekend and variable shifts as necessary