QA Analyst I: Batch Release & Documentation

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Day One Benefits Medical & Dental

Flexible Spending Accounts

401(k) Retirement Plan with Company 0%

Paid Holidays

Paid Time Off

Education Assistance

Employee Assistance Program

Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions in Bloomington, IN seeks a Quality Analyst I Batch Release to compile batch manufacturing documentation, print controlled forms from Veeva, and manage batch record sign-out/in. This role supports correction resolution and document control across the Documentation Center.

You will assist with batch record reviews, sign-off processes, and cross-functional teamwork with QA, Production, and other departments to ensure on-time batch release and ongoing quality improvement.

Qualifications

• Bachelor’s degree in a science discipline or equivalent with at least three years of Pharmaceutical Quality or Manufacturing experience.
• Demonstrated understanding of quality assurance in an FDA-regulated environment and aseptic processing operations.
• Effective organizational, technical and problem-solving skills.
• Computer proficiency in Word, Excel, Outlook and enterprise software (examples include JDE, BPLM, Pilgrim, TrackWise).

Responsibilities

• Perform final batch record review.
• Reconcile discrepancies with documentation and/or electronic systems.
• Compile documentation packets for batch manufacturing, including printing of controlled forms.
• Generate additional batch documents for batches in progress as needed.
• Manage the process of sign-out and sign-in of batch records.
• Assist personnel with correction resolution and access to executed records.
• Facilitate collaboration between QA, Production and support functions to ensure on-time batch review and release.
• Participate in continuous improvement projects to increase efficiency and quality.

Skills

Quality assurance

Organizational skills

Problem-solving

Education

Bachelor’s degree in science or related field with 3+ years pharma/manufacturing

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

JDE

BPM/L

Pilgrim

TrackWise

Job description

Simtra BioPharma Solutions in Bloomington, IN seeks a Quality Analyst I Batch Release to compile batch manufacturing documentation, print controlled forms from Veeva, and manage batch record sign-out/in. This role supports correction resolution and document control across the Documentation Center.

You will assist with batch record reviews, sign-off processes, and cross-functional teamwork with QA, Production, and other departments to ensure on-time batch release and ongoing quality improvement.