Sr. Investigator

MilliporeSigma; Indianapolis (IN); On-site; USD 104,000 - 156,000; Full time

Benefits offered by this job

Health insurance

Paid time off (PTO)

Retirement contributions

Job summary

MilliporeSigma is seeking a Sr Deviation Investigator to provide timely resolution of deviations and complaints, conducting thorough root cause investigations and implementing robust CAPAs. This role reports to the QMS Manager and participates in cross-functional collaboration with technical support and operations teams.

Qualifications include a Bachelor’s in science/engineering and at least 5 years in a pharma manufacturing setting, with 2 years focused on deviation investigations.

Qualifications

• Bachelor’s degree in a science or engineering field.
• Minimum 5 years in a pharmaceutical manufacturing site environment with at least 2 years directly supporting deviation investigations.

Responsibilities

• Process deviations and complaints within the quality management system and conduct thorough root cause investigations.
• Track deviations for area assigned to ensure on-time completion of each step.
• Assist manager in improving the quality of investigations and ensure timely closure.

Skills

Deviation investigations

Root cause analysis

CAPA implementation

Interdepartmental coordination

Microsoft Office (Excel, Word, Access,

Education

Bachelor’s degree in science or engineering

Tools

Microsoft Excel

Microsoft Word

Microsoft Access

PowerPoint

Job description

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

• Reports to QMS Manager and Quality Systems Team.
• The Sr Deviation Investigator is responsible for providing timely resolution of assigned deviations and complaints, ensuring that the investigations are thoroughly investigated to determine root cause, and that robust CAPA’s are implemented whenever necessary. The investigator will be assigned specific areas for which they will be responsible for deviation investigation.
• The investigator will coordinate with the area, technical support, and other personnel to facilitate completion of deviation investigations.
• The investigator will keep track of deviations for assigned area(s) and help to ensure deviations are evaluated and closed per timing requirements.
• Sr Deviation Investigators are generally assigned the more complex deviations as they require more experience and coordination to complete investigation.

Major Position Activities & Responsibilities

• Deviation Investigation:

  Process deviations and complaints within the quality management system and conduct thorough root cause investigations. This will require interviewing personnel involved and interacting with technical support and other personnel to determine root causes of the deviations and to assess impact. Deviation investigation will also require reviewing instructions, reference material, and documentation to understand the processes being investigated and what went wrong.

• Deviation Tracking:

  Track deviations for area assigned to help ensure on-time completion of each step.

• Scope:

  Tracking and completing deviation investigations for areas assigned and assisting manager in improving the quality of investigations.

Scope

• Tracking and completing deviation investigations for areas assigned and assisting manager in improving the quality of investigations.

Minimum Qualifications

Who You Are

• Bachelor’s degree in a science or engineering field
• Minimum of 5 years of experience required in a pharmaceutical manufacturing site environment with at least 2 of those years directly supporting deviation investigations

Preferred Qualifications

• Advanced user of Microsoft Office products, including Excel, Word, Access, and PowerPoint
• Use and system knowledge and experience of Quality Management Systems
• Ability to interface with personnel from multiple areas to deliver results (e.g., complete deviation investigation)
• Demonstrated ability to write through, clear, concise, and logically organized technical documents

Pay Range for this position: $104,100- $156,100 / year

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 includes health insurance, paid time off (PTO), retirement contributions, and other prerequisites.

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!