Lead Investigator
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
The Lead Investigator will oversee and conduct investigations in accordance with company policies, applicable cGMP FDA, EMA, and other global pharmaceutical regulations. Responsibilities include investigating deviations, leading root cause analysis, writing reports, and establishing CAPAs using SMART methodology.
Responsibilities include but are not limited to:
- Maintain oversight of the QA program from a QMS perspective, ensuring compliance and on-time closures.
- Collaborate with cross-functional teams, facilitate problem-solving, and drive continuous improvement efforts.
- Write, review, and approve Deviations, CAPAs, Complaints, as required.
- Lead and inspire cross-functional teams, fostering a culture of compliance and continuous improvement.
- Client facing meetings to drive timely closure of investigations.
- Investigate deviations/non-conformances of all levels.
- Create SMART CAPAs and Effectiveness Checks as necessary.
Who You Are:
Minimum Qualifications:
- Associates Degree in Chemical Engineering, Microbiology, or other Engineering or Life Science discipline.
- 5+ years of work experience within the pharmaceutical or biotechnology industry.
Preferred Qualifications:
- Experience with cGMP, Data Integrity, and Quality Systems.
- Experience successfully leading and managing investigations and CAPAs.
- Experience collaborating with regulatory agencies and conducting audits or inspections.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
Nearest Major Market: Indianapolis
Job Segment:
Pharmaceutical, QA, Quality Assurance, Microbiology, Science, Technology, Quality