Manufacturing Lead Investigator
Company: Takeda Pharmaceutical
Posted on: August 4, 2022
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
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
- 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
- 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
- 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
- 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
- Generous paid time off for vacation, sick leave, and
- Community Outreach Programs and company match of charitable
- 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
- 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
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