Manufacturing Lead Investigator

Company: Takeda Pharmaceutical
Location: Waukegan
Posted on: August 4, 2022

Job Description:

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:The Manufacturing Deviation Specialist reports to the Sr. Manufacturing Manager. The primary responsibilities of this role are initiating and executing deviations in support of Manufacturing. You will provides technical support to the manufacturing functions which includes filling, inspection, and packaging operations. In addition, you will works closely with the corresponding manufacturing, quality assurance, or critical system personnel to investigate suspect results. 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.
• Lead routine and complex investigations.
• 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.
• Prepare root cause and/or trend analysis to management during routine operation mechanisms (e.g. Management Review and CAPA Review Board).Minimum Requirements/Qualifications:
  • Typically requires a bachelors' degree in science, engineering or other related technical field and 2+ years of related work experience.
  • Some leadership experience preferred.
  • Technical writing experience preferred.
  • Active Yellow Belt Certification, preferred.
  • Proficient in Microsoft Office (Word, Excel, PowerPoint).
  • 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, critical system understanding and lead investigations to provide comprehensive investigation write up.
  • Capable of navigating through Quality systems and has working knowledge of event management system.What Takeda can offer you:
    • 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 paid time off for vacation, sick leave, and volunteering
    • Community Outreach Programs and company match of charitable contributions
    • Family Planning Support
    • Professional development and training opportunities
    • Tuition reimbursementImportant ConsiderationsAt Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. 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.This posting excludes Colorado applicants. 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. Locations USA - IL - Round Lake - Drug Delivery Worker Type Employee Worker Sub-Type Regular Time Type Full time

Keywords: Takeda Pharmaceutical, Waukegan , Manufacturing Lead Investigator, Other , Waukegan, Illinois