Operations Specialist I

Join to apply for the Operations Specialist I role at BioSpace 2 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description 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. How You Will Contribute 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 What You Bring To Takeda 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 Important Considerations 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 More About Us 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. Compensation and Benefits 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. EEO Statement Takeda is proud to promote diversity and provide equal employment opportunities in accordance with applicable laws. #J-18808-Ljbffr BioSpace