BioSpace
Job Description
About the Role:
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. How You Will Contribute 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 What You Bring To Takeda Typically requires bachelor's degree in science, engineering or other related technical field. Some related experience preferred Professional (GMP industry) experience ideal 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: Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas. Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. Work in a cold, wet environment. Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection. More About Us
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Takeda Compensation And Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location:
USA - GA - Social Circle - Hwy 278 U.S. Base Salary Range
$56,000.00 - $88,000.00 EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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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. How You Will Contribute 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 What You Bring To Takeda Typically requires bachelor's degree in science, engineering or other related technical field. Some related experience preferred Professional (GMP industry) experience ideal 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: Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas. Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. Work in a cold, wet environment. Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection. More About Us
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Takeda Compensation And Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location:
USA - GA - Social Circle - Hwy 278 U.S. Base Salary Range
$56,000.00 - $88,000.00 EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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