Senior Auditor
Job ID: 290631
Location: Indianapolis, Indiana, United States
Job Type: Full-time
About Us
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
We are a global leader in Healthcare, Life Science, and Electronics, driven by curiosity and innovation. Together, we push boundaries to enrich lives and shape the future.
Note: This role does not offer sponsorship for work authorization. Applicants must be eligible to work in the US.
Your Role
As a Senior Auditor, you will be responsible for ensuring compliance with cGMP, FDA, EU regulations, and internal quality standards in a pharmaceutical environment. This role involves leading audits, managing quality systems, and overseeing supplier quality to ensure operations align with regulatory and company expectations.
Key Responsibilities
Audit Management
Schedule, prepare, conduct, and report internal and external audits of manufacturing processes, quality systems, and suppliers.
Evaluate compliance with cGMP, FDA, EU, and internal standards.
Prepare detailed audit reports summarizing findings, non-conformances, and recommendations.
Collaborate cross-functionally to implement and monitor Corrective and Preventive Actions (CAPAs).
Track CAPA effectiveness and ensure timely issue resolution.
Quality System Oversight
Participate in mock inspections as needed.
Escalate compliance issues or risks identified during audits or risk assessments.
Ensure alignment with quality standards, manuals, policies, and procedures.
Supplier Quality Management
Conduct supplier audits and assessments for compliance with regulatory and quality standards.
Partner with suppliers to establish corrective actions for deficiencies.
Maintain supplier performance metrics and ensure adherence to quality agreements.
Who You Are
Minimum Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field, or equivalent experience.
Minimum 7 years of experience in QA, auditing, or supplier management within pharma, biotech, or cGMP industry.
Auditing experience within regulated biotech/pharma (or equivalent).
Willingness to travel up to 25% domestically (supplier sites, company locations).
Preferred Qualifications
Certified Quality Auditor (CQA) or equivalent certification.
Strong knowledge of cGMP, FDA, EU regulations.
Ability to interpret/apply regulatory guidance and recommend compliance improvements.
Experience in quality system management and supplier quality assurance.
Excellent analytical, communication, and problem-solving skills.
Strong organizational skills, attention to detail, and ability to work independently.
Requires limited supervision.
Compensation & Benefits
Pay Range: $101,400 – $152,000 annually
Actual compensation based on experience, skills, and location.
Eligible for performance-based bonuses.
Benefits include:
Health insurance
Paid time off (PTO)
Retirement contributions
Additional company perks
What We Offer
At MilliporeSigma, we foster inclusion, belonging, and growth for all. With diverse perspectives and backgrounds, we strengthen innovation and drive excellence in science and technology.
Apply Now
Join us and be part of a team dedicated to sparking discovery and elevating humanity.
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