Quality Assurance Specialist - Batch Records & Release

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

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Other prerequisites

Job summary

MilliporeSigma in Indianapolis is seeking a Quality Document Control and Product Release specialist for a complex parenteral manufacturing facility. You will perform Batch Record Review, Product Release, Document Control/Archival, investigations/CAPAs and Training to ensure compliance with regulatory requirements.

You will collaborate with QA, QC, Operations, Clients and Suppliers to establish and maintain release requirements and ensure products meet specifications.

Qualifications

• High School Diploma or GED required.
• 2+ years of quality assurance experience in GMP environment.
• Bachelor’s degree preferred.

Responsibilities

• Perform Batch Manufacturing Record review and product release per site SOPs.
• Review documentation for accuracy, GDP compliance and approval criteria.
• Initiate deviations/investigations in eQMS and communicate findings.
• Collaborate with QA, QC, Operations, clients and suppliers to ensure release readiness.
• Monitor batch record cycle times to support on-time disposition.

Skills

Quality assurance

Oral and written communication

Education

High School Diploma or GED

Bachelor's Degree

Job description

MilliporeSigma in Indianapolis is seeking a Quality Document Control and Product Release specialist for a complex parenteral manufacturing facility. You will perform Batch Record Review, Product Release, Document Control/Archival, investigations/CAPAs and Training to ensure compliance with regulatory requirements.

You will collaborate with QA, QC, Operations, Clients and Suppliers to establish and maintain release requirements and ensure products meet specifications.