Quality Analyst I: Batch Release (Weekend PM)

Simtra-Biopharma-Solutions; Bloomington (IN); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Medical & Dental Coverage

Flexible Spending Accounts

401(k) Retirement Savings Plan with 2%

Life and AD&D Insurance

Education Assistance Program

Job summary

Simtra BioPharma Solutions in Bloomington, IN seeks a Quality Analyst I, Batch Release, to compile and manage batch documentation, print controlled forms from Veeva, and oversee sign-in/out of batch records. Weekend 7:00 PM to 7:30 AM schedule with strong emphasis on regulatory compliance and cross-functional collaboration.

The role supports QA, Production, and Documentation Centers, ensuring on-time quality reviews and reporting to the Quality Supervisor.

Qualifications

• Bachelor's degree in a science discipline or equivalent with pharmaceutical QA experience.
• Understanding of QA in FDA-regulated environment and aseptic processing.
• Strong organizational, technical, and problem-solving skills.
• Proficient with MS Word, Excel, Outlook; able to use enterprise software.

Responsibilities

• Perform final batch record review.
• Reconcile discrepancies in documentation/electronic systems.
• Assemble documentation packets for batch manufacturing.
• Generate additional batch documents for batches in progress as needed.
• Manage sign-out/sign-in of batch records.
• Support cross-functional communication to ensure timely quality review of batch records.
• Participate in continuous improvement projects to enhance efficiency and quality.

Skills

Quality Assurance

Documentation control

Batch record review

Microsoft Office

TrackWise

Education

Bachelor's degree in science

Bachelor's degree in non-science with 3+ years pharma experience

Tools

JDE

BPLM

Pilgrim

TrackWise

Job description

Simtra BioPharma Solutions in Bloomington, IN seeks a Quality Analyst I, Batch Release, to compile and manage batch documentation, print controlled forms from Veeva, and oversee sign-in/out of batch records. Weekend 7:00 PM to 7:30 AM schedule with strong emphasis on regulatory compliance and cross-functional collaboration.

The role supports QA, Production, and Documentation Centers, ensuring on-time quality reviews and reporting to the Quality Supervisor.