Data Integrity Lead for cGMP & Audit Readiness

Millipore Corporation; 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 seeks a Data Integrity Specialist to ensure data integrity across lab, manufacturing, and IT systems supporting cGMP activities. You will develop and maintain policies, run Data Integrity assessments, and support audits with a focus on 21 CFR Part 11 compliance.

Lead trainings, coordinate investigations, update user requirements, and drive continuous improvement in data governance and system validation across the organization in the US.

Qualifications

• Bachelor's degree in CS/IT/Biology/Chemistry or Life Science.
• 10+ years with computer system validation and/or Data Integrity in pharma/medical device.

Responsibilities

• Ensure Data Integrity for all systems supporting cGMP activities across lab, manufacturing, and IT.
• Develop and maintain company policy and procedures related to Data Integrity.
• Develop training curricula and deliver training on data integrity policies site-wide.
• Provide coaching to ensure understanding of data integrity and regulatory guidelines for audits.
• Lead cGMP data life-cycle strategy and perform 21 CFR Part 11 assessments for new/upgraded systems.

Skills

Data Integrity

Computer System Validation

Regulatory Compliance

Leadership

Education

Bachelor's Degree in Computer Science, Information Technology, Biology, Chemistry, or Life Science

Job description

MilliporeSigma seeks a Data Integrity Specialist to ensure data integrity across lab, manufacturing, and IT systems supporting cGMP activities. You will develop and maintain policies, run Data Integrity assessments, and support audits with a focus on 21 CFR Part 11 compliance.

Lead trainings, coordinate investigations, update user requirements, and drive continuous improvement in data governance and system validation across the organization in the US.