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Lead Investigator
Lead InvestigatorMerck Gruppe • Indianapolis, IN, US
Lead Investigator

Lead Investigator

Merck Gruppe • Indianapolis, IN, US
8 days ago
Job type
  • Full-time
Job description

Overview

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

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 any discipline.
  • 3+ years of work experience within the pharmaceutical or biotechnology industry.
  • Preferred Qualifications :

  • Bachelors Degree in a Life Science or Engineering discipline.
  • 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.
  • Pay Range for this position : $68,200 - $109,000

    The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information, please contact the hiring team.

    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!

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