Operations Specialist

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About the Role:

As the Operations Specialist I, you will be responsible for managing investigations and Corrective/Preventive Actions (CAPAs) for manufacturing operations and accountable for closure of investigational processes to support product release.

The hours of this position are 8am to 5pm Monday through Friday; weekend and holiday work. Overtime may be required.

• Lead Deviations/CAPA investigations
• Collaborate with multiple teams (Quality, Engineering, and Technical Service)
• Manage complex investigations using DMAIC tools
• Manage records workflow in Trackwise System
• Author Investigation Reports
• Stay current with biopharmaceutical industry best practices and technologies
• Organize data and prepare appropriate documentation, including presentation materials, for assigned projects
• Ensure implementation of corrective and preventive actions
• Author and revise GMP documents and manufacturing records (e.g., Batch records, SOPs, change controls)
• Implement improvement programs to improve yield and process robustness, which may require leading and implementing change controls
• Demonstrate continuous improvement concerning job knowledge and proficiency in the biopharmaceutical industry

• Bachelor's degree in science, engineering, or related technical field; some related experience preferred
• Professional GMP industry experience ideal
• Knowledge of core manufacturing principles and support systems
• Experience working in a team-based environment preferred
• Proficiency in Excel (maintaining complex spreadsheets)
• Technical writing skills
• Ability to manage multiple priorities or projects

In this role, you may:

• Work in a controlled environment requiring gowning and protective clothing
• Remove all make-up, jewelry, contact lenses, nail polish, and artificial nails in manufacturing areas
• Work in cold, wet environments
• Work multiple shifts, including weekends, or additional hours
• Work around chemicals requiring respiratory protection
• Occasionally wear PPE such as hard hats, safety shoes, glasses, ear plugs; provided by the company

Takeda is committed to transforming patient care through innovative pharmaceuticals and support programs. We foster an inclusive, collaborative workplace dedicated to delivering Better Health and a Brighter Future worldwide.

Base salary range: $56,000 - $88,000. Actual salary depends on qualifications, experience, skills, education, and location. Benefits include incentives, insurance, 401(k), paid time off, and more.

Takeda is proud to promote diversity and provide equal employment opportunities in accordance with applicable laws.