QA Specialist – Aseptic & GMP Oversight

MilliporeSigma; Indianapolis (IN); On-site; USD 69,000 - 111,000; Full time

Benefits offered by this job

Health insurance

Paid Time Off (PTO)

Retirement contributions

Other perquisites

Job summary

MilliporeSigma in Indianapolis seeks a QA on-the-floor oversight role to ensure compliant manufacturing activities. You will review documentation, perform line clearances, and monitor aseptic processes to reinforce best practices in a GMP environment.

The position emphasizes aseptic technique expertise, documentation discipline, and collaboration with manufacturing teams to maintain product quality and regulatory compliance.

Qualifications

• Bachelor's degree in biology, chemistry or life sciences with 2+ years GMP experience.
• Alternative: high school diploma with 5+ years GMP experience.
• Experience with Excel, Word and Access preferred.
• Familiarity with SAP and quality management systems a plus.

Responsibilities

• Review documented steps to verify execution and proper documentation.
• Perform line clearances and room releases for manufacturing use.
• Review logbooks to confirm activities are completed and recorded.
• Monitor formulation and filling for cGMP compliance.
• Provide aseptic core monitoring and SME guidance on aseptic practices.

Skills

Quality Assurance

cGMP compliance

Aseptic technique

Documentation practices

Education

Bachelor's Degree in Biology, Chemistry, or Life Science

High School Diploma or GED with 5+ years GMP experience

Tools

Microsoft Excel

Microsoft Word

Microsoft Access

SAP

Quality Management Systems

Job description

MilliporeSigma in Indianapolis seeks a QA on-the-floor oversight role to ensure compliant manufacturing activities. You will review documentation, perform line clearances, and monitor aseptic processes to reinforce best practices in a GMP environment.

The position emphasizes aseptic technique expertise, documentation discipline, and collaboration with manufacturing teams to maintain product quality and regulatory compliance.