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Job DescriptionJob Title: Senior Manufacturing Investigator
Location: Round Lake, IL
The Senior Investigator will initiate and execute deviations in support of Manufacturing. Responsibilities include defining problem statements, documenting current state, conducting root cause analysis, implementing corrective actions, and verifying that the corrective actions were effective in resolving the issue. The incumbent provides technical support to the manufacturing functions which includes filling, inspection, and packaging operations. In addition, the incumbent works closely with the corresponding manufacturing, quality assurance, or critical system personnel to investigate suspect results. Responsibilities include leading investigation teams and driving root cause identification and preparing presentation for management.
How you will contribute:Conduct and document Investigation in a timely manner to support the on-time closure of non-conformances to meet product fulfillment dates.
Support problem solving sessions through application of the problem-solving tools and methods to coordinate and/or lead investigation teams. Lead routine and complex investigations.
Actively contribute to a team setting, increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support, as needed. Lead or support Deviation Free Initiatives
Work closely with other QA departments and manufacturing operations to conduct investigations, determine appropriate corrective actions, and drive closure of deviations in accordance with cGMP and quality systems.
Maintain access to key quality system databases and ensure accuracy of those databases as they pertain to CAPA and other quality databases.
Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Investigate deviations and write exception documents, when assigned.
Ensure training requirements are met and that training records are current. Train and mentor other team members and support training for newer team members.
Prepare root cause and/or trend analysis to management during routine operation mechanisms (e.g., Management Review and CAPA Review Board).
Ability to work independently.
Active Yellow Belt Certification, preferred.
Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
Effective organizational skills, detail oriented, and ability to plan and suggest resolutions to technical or resource problems.
Proficient in Microsoft Office (Word, Excel, PowerPoint).
Effective interpersonal communication and influencing skills. Must have effective verbal and written communication skills.
Understand scientific strategies and be able to create new processes or new avenues of investigation.
Must be able to understand and apply cGMP/GOP, follow CTP/SOPs, and meet EHS requirements.
Demonstrate good process and critical system understanding to create comprehensive investigation write up.
Capable of navigating through Quality systems and has working knowledge of event management system.
High School Diploma or GED plus 5+ years of related experience OR Bachelors' degree in science, engineering or other related technical field and 2+ years of related experience. Technical writing experience preferred.
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs and company match of charitable contributions
Family Planning Support
Professional training and development opportunities
Tuition reimbursement
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 and walking around observing conditions in the facility.
May be required to work in a confined area.
Some clean room and cool/hot storage conditions.
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.
Will need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
May work in a cold, hot or wet environment.
May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
Must be able to work multiple shifts, flexible hours, including weekends and holidays to support a 24/7 site.
May be required to work or be assigned to a different shift as needed.
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.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This posting excludes Colorado applicants.
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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.
LocationsUSA - IL - Round Lake - Drug DeliveryWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
